FDA Adverse Event Injury Summary report: N

REVITAN, DISTAL PART, CURVED, UNCEMENTED, 18/140

MDR report key: 10137670 · Received June 10, 2020

Report

Report Number: 0009613350-2020-00252
Event Type: Injury
Date Received: June 10, 2020
Date of Event: May 3, 2019
Report Date: October 15, 2021
Manufacturer: ZIMMER SWITZERLAND MANUFACTURING GMBH
Product Code: KWA
PMA / PMN Number: N/A
Removal / Correction Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. D10: MEDICAL PRODUCTS: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 95, TAPER 12/14; CATALOG#: 01.00402.095; LOT#: 2770087 ALLOFIT ALLOCLASSIC SHL 58/LL; CATALOG#: 4248; LOT#: 2774312 DURASUL, ALPHA INSERT, LL32; CATALOG#: 01.00013.412; LOT#: 2772422 COCR HEAD, XL, 32/+8, TAPER 12/14; CATALOG#: 01.01012.328; LOT#: 2773424 THERAPY DATE: (B)(6) 2019. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL INFORMATION WAS RECEIVED ON SEP 08, 2021. ADDITIONAL: A1, B7, D9, D10 CORRECTION: B4, B5, D2, E1, G2, G3, G6, H2, H10. THE MANUFACTURER RECEIVED X-RAYS, OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICES BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION RECEIVED ON 2021-04-07: - LEGAL LETTER RECEIVED (COMPLAINT TURNED INTO A LEGAL COMPLAINT) - DOB RECEIVED (B)(6) 1969. - AN ADDITIONAL SURGICAL REPORT IS EXPECTED TO BE RECEIVED. (AS SOON AS THIS SURGRICAL REPORT HAS BEEN RECEIVED, AN UPDATED REPORT WITH UPDATED INVESTIGATION WILL BE SUBMITTED). INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: H2 CORRECTION: A2, B4, B5, G3, G6, H10. DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. OUR LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Additional Manufacturer Narrative · 0

THE INVESTIGATION RESULTS HAVE BEEN UPDATED AS THE PRODUCT WAS RETURNED TO ZIMMER SWITZERLAND MANUFACTURING GMBH. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A REVITAN STEM ON (B)(6) 2015 ON THE RIGHT SIDE. ON (B)(6) 2019 WHILE DESCENDING FROM A TRANSPORTER (10-20 CM) THE PATIENT HEARD A CRACK IN THE AFFECTED HIP. SINCE THE EVENT THE PATIENT HAD LOAD-DEPENDENT PAIN. THE RADIOGRAPHS SHOWED A STEM FRACTURE AT THE CONNECTION BETWEEN DISTAL AND PROXIMAL PART, WHICH WAS CONFIRMED INTRAOPERATIVELY DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2019. REVIEW OF RECEIVED DATA: - MEDICAL REPORTS: MEDICAL LETTER, (B)(6) 2014: THE PATIENT IS 186 CM TALL AND WEIGHS 120 KG. NOTE OF THE AUTHOR: THE GIVEN HEIGHT AND WEIGHT OF THE PATIENT RESULTS IN A BMI OF 34.7 WHICH CAN BE CLASSIFIED AS OBESE CLASS I ACCORDING TO THE BMI SCALE (BMI 30.0 ¿ 34.9) (1). IMPLANTATION REPORT OF (B)(6) 2014, (B)(6), DR. (B)(6): DIAGNOSIS: POST TRAUMATIC COXARTHROSIS, RIGHT HIP SURGERY: IMPLANTATION OF A CEMENTLESS TOTAL HIP PROSTHESIS (THP) ¿ ALLOFIT CUP, NEUTRAL PE INSERT, SPOTORNO STEM, COCR HEAD. IMPLANT CARD, (B)(6) 2014: THE FOLLOWING IMPLANTS WERE IMPLANTED ON (B)(6) 2014 ACCORDING TO THE AFFIXED IMPLANT STICKERS: ALLOFIT SHELL, SIZE 56/KK, REF. 4247, LOT 2736284. DURASUL ALPHA INSERT, SIZE KK/32, REF. 01.00013.411, LOT 2761955. CLS SPOTORNO STEM, SIZE 15, REF. 29.00.39-150, LOT 2762386. COCR HEAD, SIZE 32XL, REF. 01.01012.328, LOT 2755625. RADIOLOGICAL REPORT OF X-RAYS TAKEN ON (B)(6) 2014: NORMAL POSITION OF THE CEMENTLESS THP. CUP INCLINATION ANGLE IS 33°. RADIOLOGICAL REPORT OF X-RAYS TAKEN ON (B)(6) 2014: IMPLANTATION OF A CEMENTLESS THP IN THE RIGHT HIP WITH NORMAL POSITION OF THE IMPLANTS. NO INDICATION FOR A PERIPROSTHETIC FRACTURE. LAB RESULTS, LABOR DR. (B)(6) : WOUND SWAB TAKEN ON (B)(6) 2014: S. AUREUS METHICIL. - RES. (MRSA) ¿ ABUNDANT. NASAL AND MOUTH SWABS TAKEN ON 01 DEC 2014: S. AUREUS METHICIL. - RES. (MRSA) ¿ DETECTABLE. LAB RESULTS, DR (B)(6) : WOUND SWAB TAKEN (B)(6) NOV 2014: S. AUREUS METHICIL. - RES. (MRSA) ¿ ABUNDANT. LAB RESULTS, DR. (B)(6) : THROAT AND NOSE SWABS TAKEN ON (B)(6) 2014: NO EVIDENCE OF MRSA. SURGICAL REPORT OF (B)(6) 2014, (B)(6) , DR. (B)(6): DIAGNOSIS: PERIPROSTHETIC INFECTION OF THE RIGHT HIP JOINT. OPERATION: OPEN SURGICAL REVISION OF THE RIGHT HIP JOINT AND APPLICATION OF A VACUSEAL-SYSTEM. PROCEDURE: AN ABSCESS WAS FOUND UNDER THE FASCIA, SAMPLES WERE TAKEN AND A VACUSEAL-SYSTEM WAS ADDED. LAB RESULTS, LABOR DR. (B)(6): WOUND SWABS TAKEN ON (B)(6) 2014: STAPHYLOCOCCUS EPIDERMIDIS ¿ ABUNDANT. SURGICAL REPORT OF (B)(6) 2014, (B)(6), DR. (B)(6): DIAGNOSIS: INFECTION OF A THP, RIGHT HIP TREATED WITH VACUSEAL DRESSING PROCEDURE: REMOVAL OF THE VACUSEAL SYSTEM AND REVISION OF THE HEAD AND PE INSERT. JET LAVAGE. PRODUCT STICKERS, (B)(6) 2014: THE FOLLOWING IMPLANTS WERE IMPLANTED ON (B)(6) 2014 ACCORDING TO THE AFFIXED IMPLANT STICKERS: COCR HEAD, SIZE 32XL, REF. 01.01012.328, LOT 2726745. DURASUL ALPHA INSERT, SIZE KK/32, REF. 01.00013.411, LOT 2769010. RADIOLOGICAL REPORT OF X-RAYS TAKEN ON (B)(6) 2014: NORMAL POSITION OF THE IMPLANTS. RADIOLOGICAL REPORT OF X-RAYS TAKEN ON (B)(6) 2015: NORMAL POSITION OF THE CEMENTLESS THP. SURGICAL REPORT OF (B)(6) 2015, (B)(6) , DR. (B)(6) : DIAGNOSIS: INFECTION OF THE RIGHT HIP THP. PROCEDURE: REMOVAL OF THE THP AND IMPLANTATION OF AN ANTIBACTERIAL SPACER IN THE RIGHT HIP JOINT. LAB RESULTS, DR (B)(6): SWABS FROM (B)(6) 2015: STAPHYLOKOKKUS EPIDERMIDIS (MRSE) UND PROPRIONIBACTERIUM ACNES ¿ SPARSELY. RADIOLOGICAL REPORT OF X-RAYS TAKEN ON (B)(6) 2015: IMPLANTATION OF A SPACER - CONVENTIONAL MONO-BLOCK THAT WAS LIGHTLY CEMENTED IN PLACE. PREPARATION OF A CUP FROM PALACOS. NO BONE LOSS. RADIOLOGICAL REPORT OF X-RAYS TAKEN ON (B)(6) 2015: THE IMPLANTED SPACER WITH A SMALL CEMENT MANTLE AT THE STEM AND AROUND THE HEAD (MONOBLOC) IS VISIBLE. THERE ARE NO CHANGES COMPARED TO THE PREVIOUS IMAGES. NO OSTEOLYSIS. SURGICAL REPORT OF (B)(6) 2015, (B)(6) , DR. (B)(6) : DIAGNOSIS: PERIPROSTHETIC INFECTION OF THE RIGHT THP, STATE AFTER IMPLANTATION OF A SPACER. PROCEDURE: REMOVAL OF THE SPACER AND IMPLANTATION OF THE CEMENTLESS REVISION PROSTHESIS USING AN ENDOFEMORAL APPROACH (ALLOFIT CUP SIZE 48, REVITAN DISTAL STEM SIZE 18-140, REVITAN PROXIMAL STEM SIZE 95, COCR HEAD SIZE XL). PRODUCT STICKERS, (B)(6) 2015: APART FROM THE REVITAN STEM, DURASUL INSERT AND CO CR HEAD THE FOLLOWING PRODUCT WAS ALSO IMPLANTED ON (B)(6) 2015, ACCORDING TO THE AFFIXED PRODUCT STICKERS: ALLOFIT SHELL, SIZE 58/LL, REF. 4248, LOT 2774312. RADIOLOGICAL REPORT OF X-RAYS TAKEN ON (B)(6) 2015: STATE AFTER IMPLANTATION OF THE REVISION THP ON THE RIGHT SIDE. NORMAL POSITION OF THE IMPLANTS. RADIOLOGICAL REPORT OF X-RAYS TAKEN ON (B)(6) 2015: STATE AFTER IMPLANTATION OF A CEMENTLESS REVISION STEM ON THE RIGHT SIDE. NORMAL POSITION OF THE IMPLANTS IN THE BONE BUT THE PROSTHESIS IS DISLOCATED AND THE FEMUR IS DISPLACED CAUDALLY APPROXIMATELY 4 CM. SURGICAL REPORT OF (B)(6) 2015, DR. (B)(6): DIAGNOSIS: DISLOCATION OF THE RIGHT HIP PROSTHESIS. OPERATION: CLOSED REDUCTION. PROCEDURE: THE DISLOCATION IS RELATIVELY EASY TO REDUCE BY PULLING ON THE LEG. NO SNAPPING IN PLACE IS DETECTABLE, SO THAT A RE-DISLOCATION WOULD BE RELATIVELY EASILY POSSIBLE. THE HIP JOINT IS MOVED IN ALL DIRECTIONS, BUT NO RE-DISLOCATION OCCURS. THERE IS A CLEAR TENDENCY TO EXTERNAL ROTATION IN THE RECUMBENT LEG. THE LEG IS POSITIONED IN A FOAM SPLINT. RADIOLOGICAL REPORT OF X-RAYS TAKEN ON (B)(6) 2015: AFTER REDUCTION OF THE RIGHT HIP PROSTHESIS THERE IS A NORMAL POSITION AGAIN, WHEREBY THE CUP IS PLACED TOO FAR CRANIALLY - CLEARLY CRANIAL TO KÖHLER TEARDROP. THE CENTER OF ROTATION OF THE FEMORAL HEAD IS CLEARLY ABOVE THE TROCHANTERIC TIP. MEDICAL LETTER, (B)(6) 2019: PATIENT CONSULTATION ON (B)(6) 2019: DIAGNOSIS: FRACTURE OF THE STEM AT THE CONNECTION PIN. ANAMNESIS: THE PATIENT HAS PERSISTENT HIP JOINT COMPLAINTS ON THE RIGHT SIDE. HE REPORTS THAT ON (B)(6) 2019, DURING A MOVEMENT, HE STEPPED DOWN ABOUT 10 - 20 CM FROM A TRANSPORTER, WHERE HE HEARD A CRACKING SOUND IN THE RIGHT HIP JOINT. SINCE THEN, THERE ARE LOAD-DEPENDENT COMPLAINTS, PAIN AT REST AND AT NIGHT ARE NOT REPORTED. X-RAYS TAKEN ON 06 JUN 2019: THEY SHOW AN IMPLANT FRACTURE IN THE AREA OF THE CONNECTION PIN. OTHERWISE, NO EVIDENCE OF LYSIS, LOOSENING OR BONY LESION. SURGICAL REPORT OF (B)(6) 2019: DIAGNOSIS: FRACTURE OF THE REVITAN STEM AT THE CONNECTION PIN. PROCEDURE: THE FRACTURED PROXIMAL PART, THE HEAD AND THE INSERT ARE REMOVED VIA A LATERAL TRANSGLUTEAL APPROACH. AN OSTEOTOMY IS PERFORMED USING FLUOROSCOPY AND THE DISTAL PART OF THE STEM IS REMOVED WITH THE HELP OF CHISELS. AN INSERT FOR A 36 MM HEAD IS IMPLANTED. THE BONE FLAP OF THE OSTEOTOMY IS FIXED WITH CERCLAGES. A PETER BREHM REVISION STEM SIZE 16X260 MM, A PROXIMAL STEM PART SIZE L WITH A 12/14 TAPER AND A HEAD SIZE 36L ARE IMPLANTED. MEDICAL LETTER, (B)(6) 2019, (B)(6): PATIENT CONSULTATION ON (B)(6) 2019: DIAGNOSIS: FOLLOW-UP CONSULTATION DUE TO PERSISTENT WOUND SECRETION AFTER REVISION OF THE RIGHT HIP JOINT ON (B)(6) 2019. MEDICAL LETTER, (B)(6) 2019, (B)(6): PATIENT CONSULTATION ON (B)(6) 2019: DIAGNOSIS: STATE AFTER REVISION OF THE RIGHT HIP PROSTHESIS ON 09 AUG 2019 WITH REMOVAL OF THE LOOSE STEM AND CUP AND IMPLANTATION OF A CEMENTLESS THP (AVANTAGE CUP SIZE 62 MM, PE LARGE HEAD FOR THE 62 MM CUP, 28 MM CERAMIC HEAD AND PETER BREHM STEM SIZE 18X260 CURVED WITH PROXIMAL PART SIZE M). RECURRENT DISLOCATION OF THE RIGHT HIP PROSTHESIS ON (B)(6) AND (B)(6) WITH SUBSIDENCE OF THE STEM. INTRAOPERATIVE DETECTION OF ENTEROCCUS FAECALIS. OBESITY. ANAMNESIS: THE PATIENT REPORTS A SENSORY DISTURBANCE OF THE LOWER LEG AS WELL AS A FLEXION DEFICIT OF THE HIP JOINT AND EXTENSION DEFICIT OF THE KNEE JOINT, MOST LIKELY IN THE SENSE OF A FEMORAL NERVE LESION. X-RAYS TAKEN ON (B)(6) 2019: COMPARED TO THE IMAGES TAKEN ON (B)(6) 2019 THERE IS A SUBSIDENCE OF THE STEM OF APPROXIMATELY 2-3 CM. THERE IS NO EVIDENCE OF LOOSENING, IN PARTICULAR NO RADIOLUCENT LINE OR DISLOCATION. NO EVIDENCE OF A FRESH BONY LESION OR FRACTURE. NOTE OF THE AUTHOR: THERE SEEMS TO BE A TYPO IN THE MEDICAL LETTER, THE X-RAYS SECTION REFERS TO X-RAYS TAKEN ONE WEEK AFTER THE PATIENT CONSULTATION. MEDICAL LETTER, (B)(6) 2019, (B)(6) : PATIENT CONSULTATION ON (B)(6) 2019: DIAGNOSIS: RE-SUBSIDENCE AS WELL AS SUSPICION OF FEMORAL NERVE LESION AFTER REVISION OF THE RIGHT HIP PROSTHESIS ON (B)(6) 2019. X-RAYS TAKEN ON (B)(6) 2019: COMPARED TO THE IMAGES OF (B)(6) 2019 THERE IS NO FURTHER SIGNIFICANT SUBSIDENCE OF THE STEM. MEDICAL LETTER, (B)(6) 2019, (B)(6): PATIENT CONSULTATION ON (B)(6) 2019: DIAGNOSIS: REPEATED SUBSIDENCE OF THE STEM AND SUSPICION OF PERSISTENT FEMORAL NERVE LESION. X-RAYS TAKEN ON (B)(6) 2019: COMPARED TO THE IMAGES OF (B)(6) 2019 THERE IS A FURTHER SUBSIDENCE OF THE STEM OF APPROXIMATELY 18 MM. - X-RAYS: X-RAYS SHOWING THE SITUATION IN THE LEFT HIP FROM (B)(6) 2019 UNTIL (B)(6) 2019 ARE AT HAND. THERE ARE DIFFERENCES IN BRIGHTNESS AND CONTRAST THROUGHOUT THE X-RAY FOLLOW-UP AS WELL AS DIFFERENCES IN THE POSITIONING OF THE PATIENT RESULTING IN SLIGHT DIFFERENT RADIOGRAPHIC PROJECTIONS. THUS, POTENTIAL CHANGES OF THE BONE SITUATION AROUND THE PROSTHESIS AS WELL AS THE POSITION OF THE PROSTHESIS COMPONENTS ARE NOT ALWAYS CLEARLY RECOGNIZABLE. THE EVALUATION OF THE X-RAYS IS SUMMARIZED BELOW. THE X-RAYS SHOWING THE SITUATION AFTER THE REVISION OF THE REVITAN STEM ON (B)(6) 2019 ARE NOT EVALUATED. PELVIS OVERVIEW AND SECOND VIEW OF THE RIGHT HIP, (B)(6) 2019: THE PELVIS OVERVIEW SHOWS A FRACTURE OF THE REVITAN STEM AT THE CONNECTION PIN. ON BOTH THE PELVIS OVERVIEW AND SECOND VIEW, THE PROXIMAL STEM PART IS TILTED MEDIALLY. THE TILTING OF THE PROXIMAL STEM PART EXPOSES LATERALLY A RADIOLUCENT GAP THAT IS BORDERED BY A SCLEROTIC LINE ON THE BONE SIDE. DUE TO THE TILT, THE PROXIMAL STEM PART IS RESTING ON THE MEDIAL CORTICAL BONE WHICH IS UNREMARKABLE. THE PROXIMAL PART OF THE CUP AND A PORTION OF THE TROCHANTER MAJOR ARE NOT VISIBLE IN THE PELVIS OVERVIEW. PELVIS OVERVIEW AND SECOND VIEW OF THE RIGHT HIP, (B)(6) 2019: COMPARED WITH THE PREVIOUS STUDY DATE, THE DISTAL END OF THE PROXIMAL STEM PART IS SHIFTED LATERALLY. CONSEQUENTLY, ALONG THE ENTIRE MEDIAL SIDE OF THE PROXIMAL STEM PART A RADIOLUCENT GAP IS SEEN. PRODUCT EVALUATION: THE CONNECTION PIN OF THE REVITAN STEM IS FRACTURED IN THE NON-BLASTED AREA. THE FRACTURE IS LOCATED APPROXIMATELY 1 TO 4 MM BELOW THE PROXIMAL END OF THE DISTAL PART. THE PROXIMAL PART OF THE CONNECTION PIN IS STILL ASSEMBLED TO THE PROXIMAL PART OF THE REVITAN STEM. THE PROXIMAL AND DISTAL FRACTURE SURFACES SHOW A FATIGUE FRACTURE STARTING FROM THE LATERAL SIDE. IN THIS REGION, TWO, POSSIBLY THREE, ADJACENT FRACTURE PLANES ARE RECOGNIZABLE WHICH THEN COMBINE TO FORM A SINGLE PLANE. THE LATERAL SIDE OF BOTH FRACTURE SURFACES IS DARK DISCOLORED. ON BOTH FRACTURE SURFACES POLISHED AREAS CAN BE RECOGNIZED ALL AROUND THE EDGE. DAMAGE FROM CONTACT BETWEEN THE PARTS AFTER THE FRACTURE CAN BE SEEN ON THE MIDDLE REGION OF THE DISTAL FRACTURE SURFACE. MACROSCOPICALLY, AS FAR AS VISIBLE, NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE WERE FOUND ON THE FRACTURE SURFACES. ON THE PROXIMAL STEM PART, A WEAR MARK CAN BE SEEN ON THE POSTEROMEDIAL EDGE OF THE FACE SURFACE AND ON THE MEDIAL EDGE OF THE MEDIAL SHOULDER. SLIGHT POLISHING CAN BE OBSERVED ON THE EDGE OF THE POSTERIOR FACE SURFACE AND ON THE LATERAL EDGE OF THE LATERAL SHOULDER. THE LATERAL FACE SURFACE AND THE LATERAL INSIDE OF THE DISTAL STEM BODY SHOW WEAR AND DEFORMATION. THERE ARE SLIGHT WEAR MARKS ON THE INSIDE OF THE POSTERIOR SHOULDER AND POSTEROMEDIAL STEM BODY. THE MEDIAL FACE SURFACE OF THE STEM BODY SHOWS A POLISHED AREA AND DAMAGE FROM REVISION SURGERY). ON THE PROXIMAL PART OF THE REVITAN STEM, REVISION DAMAGE IN THE FORM OF SCRATCHES AND INSTRUMENT MARKS CAN BE SEEN MAINLY IN THE NECK AND SHOULDER REGIONS. ON THE ANTERIOR, MEDIAL AND LATERAL SIDE OF THE STEM¿S NECK SEVERAL COLORED SPOTS CAN BE OBSERVED, MOST PROBABLY FROM THE USE OF AN ELECTROSURGICAL INSTRUMENT DURING SURGERY. SEVERAL POLISHED HORIZONTAL LINES CAN BE SEEN ON THE ANCHORING SURFACE ON THE POSTERIOR SIDE, MEDIAL SIDE AND SLIGHTLY ON THE ANTERIOR SIDE. THE DISTAL END OF THE LATERAL SIDE IS POLISHED AS WELL. THERE ARE NO SIGNS OF BONE ONGROWTH ON THE ANCHORING SURFACE OF THE PROXIMAL STEM PART. ON THE PROXIMAL FRACTURE PART OF THE CONNECTION PIN THERE IS A HALF CIRCUMFERENTIAL STRIPE WITH SURFACE CHANGES ADJACENT TO THE FRACTURE SURFACE. CLOSER INSPECTION OF THE STRIPE WITH A LOW POWER MICROSCOPE (LEICA MZ16 A) REVEALED POLISHING, SMEARED MATERIAL AND SOME SIGNS OF FRETTING AND CORROSION. ON THE MEDIAL AND ANTERIOR SIDE OF THE STRIPE SEVERAL BREAK-OUTS CAN BE NOTICED CLOSE TO THE EDGE OF THE FRACTURE SURFACE WHICH IS DEFORMED OUTWARDS OR ROUNDED INWARDS, RESPECTIVELY. ADJACENT TO THE STRIPE JOINS THE BLASTED AREA. ON THE LATTER A SMALL POLISHED AREA CAN BE SEEN ON THE POSTERIOR SIDE. REVISION DAMAGE IN THE FORM OF COARSE SCRATCHES AND INSTRUMENT MARKS ARE VISIBLE ON THE ANCHORING SURFACE OF THE DISTAL PART OF THE REVITAN STEM. BONE ATTACHMENTS ARE VISIBLE ON THE ENTIRE ANCHORING SURFACE. THE COCR HEAD (STILL MOUNTED ON THE PROXIMAL STEM PART) AND THE DURASUL ALPHA INSERT WERE INSPECTED. HOWEVER NOTHING WAS OBSERVED THAT COULD HAVE HAD AN INFLUENCE ON THE FRACTURE OF THE CONNECTION PIN AND THEREFORE THEY ARE NOT FURTHER DESCRIBED. REVIEW OF PRODUCT DOCUMENTATION: - DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. - DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. CONCLUSION: FOLLOWING A MRSA INFECTION, ON (B)(6) 2015 THE ANTIBACTERIAL SPACER WAS REMOVED AND A NEW THP WAS IMPLANTED IN THE RIGHT HIP (ALLOFIT CUP, DURASUL INSERT, REVITAN STEM AND COCR HEAD). FEW DAYS AFTER THE SURGERY THE PATIENT SUFFERED A DISLOCATION OF THE PROSTHESIS AND A CLOSED REDUCTION WAS PERFORMED ON (B)(6) 2015. APPROXIMATELY 4 YEARS LATER, ON (B)(6) 2019, THE PATIENT REPORTED A CRACKING SOUND IN THE RIGHT HIP JOINT AND AN X-RAY CHECK ON (B)(6) 2019 SHOWED A FRACTURE OF THE REVITAN STEM AT THE CONNECTION PIN. THE REVITAN STEM WAS REVISED ON (B)(6) 2019 TOGETHER WITH THE HEAD AND INSERT. THE REVISED COMPONENTS WERE RECEIVED FOR INVESTIGATION. THE FRACTURE OF THE REVITAN STEM OCCURRED DUE TO FATIGUE IN THE NON-BLASTED AREA OF THE CONNECTION PIN, FEW MILLIMETERS BELOW THE PROXIMAL END OF THE DISTAL STEM PART. THE FRACTURE ORIGIN AREA IS LOCATED ON THE LATERAL SIDE OF THE STEM. MACROSCOPICALLY, AS FAR AS VISIBLE, NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE COULD BE FOUND ON THE FRACTURE SURFACES. ON THE PROXIMAL FRACTURE PART OF THE PIN THERE IS A HALF CIRCUMFERENTIAL STRIPE REVEALING A MIXTURE OF SURFACE CHANGES. IT IS UNKNOWN IF THE STRIPE EXISTED ALREADY BEFORE THE START OF THE FRACTURE OR DEVELOPED EXCLUSIVELY AS A CONCOMITANT PHENOMENON. BONE ATTACHMENTS COULD BE OBSERVED ON THE DISTAL PART OF THE REVITAN STEM BUT NOT ON THE PROXIMAL PART. FURTHER, POLISHED HORIZONTAL LINES CAN BE SEEN ON THE ANCHORING SURFACE OF THE PROXIMAL PART WHICH INDICATES MOVEMENT BETWEEN THE PART AND THE BONE. IT IS UNKNOWN IF THESE EXISTED ALREADY BEFORE THE START OF THE FRACTURE AND ARE ASSOCIATED WITH IT OR DEVELOPED EXCLUSIVELY AS A CONCOMITANT. THERE ARE ONLY X-RAYS AT HAND TAKEN ONE MONTH AND ONE DAY BEFORE THE REVISION OF THE REVITAN STEM. THEY SHOW EVIDENCE OF A RADIOLUCENT GAP ALONG THE MEDIAL AND LATERAL SIDE OF THE PROXIMAL STEM PART. FURTHER, IT COULD BE OBSERVED THAT THE DISTAL STEM PART WAS WELL FIXED. RADIOLOGICAL REPORTS OF X-RAYS TAKEN IN (B)(6) 2015 AND (B)(6) 2015 STATE A NORMAL POSITION OF THE IMPLANTS BUT THERE IS NO STATEMENT ABOUT THE BONE CONDITION AROUND THE REVITAN STEM. THUS, AS THE COMPLETE X-RAY FOLLOW-UP IS NOT AT HAND, THE BONE SITUATION AROUND THE REVITAN STEM FROM IMMEDIATELY AFTER THE IMPLANTATION AND HOW IT DEVELOPED OVER TIME IN VIVO STAYS UNKNOWN. TODAY IT IS KNOWN THAT FOR PATIENTS WITH SEVERE PROXIMAL DEFICIENCY, A SURGEON SHOULD CONSIDER SURGICAL OPTIONS TO ENSURE PROXIMAL BONE SUPPORT (SUCH AS MEDIAL AND/OR LATERAL STRUT GRAFTS) OR SWITCHING TO A MONOBLOC REVISION STEM (2). AT THE TIME OF IMPLANTATION IN (B)(6) 2015 THIS WAS NOT KNOWN AND RESPECTIVE GUIDANCE COULD NOT BE PROVIDED TO THE SURGEON. BASED ON THE ABOVE DESCRIBED FINDINGS AND TODAY¿S KNOWLEDGE, IT CAN ONLY BE ASSUMED THAT FROM A BIOMECHANICAL POINT OF VIEW THE PROXIMAL BONE SUPPORT OF THE REVITAN STEM WAS SUBOPTIMAL DURING THE TIME IN VIVO. THE BONE SUPPORT SITUATION IN COMBINATION WITH OTHER FACTORS, E.G. THE SURFACE CHANGES OBSERVED ON THE CONNECTION PIN AND THE PATIENT¿S WEIGHT OF 120 KG, MAY HAVE CONTRIBUTED TO THE SEQUENCE OF EVENTS FINALLY RESULTING IN THE FATIGUE FRACTURE OF THE STEM. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED EVENT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4). REFERENCES: (1) WIKIPEDIA BODY-MASS-INDEX ACCESSED ON (B)(6) 2021. HTTPS://EN.WIKIPEDIA.ORG/WIKI/BODY_MASS_INDEX. (2) REVITAN STRAIGHT REVISION HIP SYSTEM - SURGICAL TECHNIQUE, 06.01109.012X - REV. 2 2016-11 A4.

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION WHICH WAS RECEIVED ON SEP 09, 2020. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE OR AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Additional Manufacturer Narrative · 0

EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A REVITAN STEM ON (B)(6)2015 ON THE RIGHT SIDE. ON (B)(6)2019 WHILE DESCENDING FROM A TRANSPORTER (10-20 CM) THE PATIENT HEARD A CRACK IN THE AFFECTED HIP. SINCE THE EVENT THE PATIENT HAD LOAD-DEPENDENT PAIN. THE RADIOGRAPHS SHOWED A STEM FRACTURE AT THE CONNECTION BETWEEN DISTAL AND PROXIMAL PART, WHICH WAS CONFIRMED INTRAOPERATIVELY DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2019. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. X-RAYS: THE FOLLOWING X-RAY ANALYSIS HAS BEEN PERFORMED BY A RADIOLOGIST. IN TOTAL FOUR, TWO AP LOWER PELVIS AND TWO OBLIQUE RIGHT HIP, VIEWS HAVE BEEN RECEIVED. THE IMAGES THEMSELVES ARE UNDATED, BUT IT WAS STATED THAT TWO IMAGES WERE TAKEN ON (B)(6)2019 AND 2 IMAGES ON (B)(6)2019. THE IMAGES SHOW A FRACTURE OF THE FEMORAL IMPLANT WITH SLIGHT SEPARATION AND MILD VARUS ALIGNMENT AT THE FRACTURE SITE. THE IMPLANT FRACTURE IS AT THE INFERIOR MARGIN OF THE LESSER TROCHANTER. AN OSSEOUS FRACTURE IS NOT IDENTIFIED. THERE IS NO DISLOCATION. APART FROM THE FRACTURE, NO ABNORMALITY OF IMPLANT POSITION IS NOTED. AS A RESULT OF THE FEMORAL IMPLANT FRACTURE, THE IMPLANT IS LOOSE. THE ACETABULAR IMPLANT ABDUCTION ANGLE MEASURES APPROXIMATELY 47 DEGREES. BONE QUALITY APPEARS UNREMARKABLE. SURGICAL REPORT: REVISION REPORT, DATED JUL 04, 2019: DIAGNOSIS: STEM FRACTURE BETWEEN DISTAL AND PROXIMAL PART, RIGHT HIP. CONDITION AFTER TWO-STAGE HTEP REPLACEMENT DUE TO PERIPROSTHETIC HIP INFECTION (MRSE CONFIRMED) 2015 AT DIFFERENT CLINIC AND CONDITION AFTER HTEP INITIAL IMPLANTATION 2014 AT DIFFERENT CLINIC. ANAMNESIS: LOAD-DEPENDENT PAIN IN THE RIGHT HIP JOINT. NO CLINICAL OR LABORATORY INDICATION OF A RE-INFECTION. DESCRIPTION OF PROCEDURE: INTRAOPERATIVELY NO INDICATION OF A RE-INFECTION. OSTEOTOMY FOR REMOVAL OF THE DISTAL REVITAN COMPONENT. IMPLANTATION OF NEW COMPONENTS. PATIENT DATA: (B)(6), MALE, BORN IN 1969, 114 KG, 184 CM, BMI: 33.7. PRODUCT EVALUATION: THE PRODUCTS REMAIN THE PROPERTY OF THE PATIENT AND HAVE NOT BEEN SENT IN FOR EXAMINATION. THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. CONCLUSION: THE PATIENT HAD AN INITIAL HTEP IMPLANTATION IN 2014 WHICH WAS REVISED IN A TWO-STAGE REVISION IN 2015 DUE TO A PERIPROSTHETIC INFECTION (MRSE). DURING THE SECOND REVISION SURGERY ON (B)(6)2015 THE REVITAN STEM WAS IMPLANTED ON THE RIGHT SIDE. ON (B)(6)2019 WHILE DESCENDING FROM A TRANSPORTER (10-20 CM) THE PATIENT HEARD A CRACK IN THE AFFECTED HIP. RADIOGRAPHS SHOWED A STEM FRACTURE, WHICH WAS CONFIRMED INTRAOPERATIVELY DURING REVISION ON (B)(6)2019. ACCORDING TO THE REVISION REPORT, THERE WAS NEITHER CLINICAL, LABORATORY NOR INTRAOPERATIVE INDICATION OF A RE-INFECTION. BASED ON THE RECEIVED X-RAYS A PIN FRACTURE OF THE DISTAL REVITAN COMPONENT CAN BE CONFIRMED. ONLY X-RAYS, TAKEN AFTER THE STEM FRACTURE, HAVE BEEN RECEIVED. THE OBTAINED RADIOGRAPHS MAY INDICATE INSUFFICIENT MEDIAL BONE SUPPORT OF THE PROXIMAL REVITAN COMPONENT PRIOR TO THE FRACTURE. NEVERTHELESS, SINCE THERE ARE NO IMAGES THAT SHOW THE THA DURING THE TIME IN-VIVO BETWEEN IMPLANTATION IN 2015 AND BEFORE THE FRACTURE IN 2019, NEITHER THE IMPLANT POSITIONING NOR THE PROXIMAL MEDIAL BONY SUPPORT AS WELL AS CHANGES THEREOF DURING THE TIME IN-VIVO COULD NOT BE EVALUATED. THE PARTS HAVE NOT BEEN RETURNED FOR EXAMINATION; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). IN CONCLUSION, BASED ON THE INVESTIGATION IT IS POSSIBLE THAT AN INSUFFICIENT MEDIAL BONY SUPPORT OF THE PROXIMAL REVITAN COMPONENT COMBINED WITH THE PATIENT'S INCREASED BMI AND POSSIBLY THE LARGE HEAD OFFSET (XL OFFSET +8) HAS INCREASED THE RISK OF FRACTURE. NEVERTHELESS, DUE TO THE UNAVAILABILITY OF THE COMPONENTS AND DUE TO THE MISSING X-RAY FOLLOW-UP, COVERING THE COMPLETE TIME IN-VIVO, AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).