REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/200
Report
- Report Number
- 0009613350-2019-00120
- Event Type
- Injury
- Date Received
- March 12, 2019
- Date of Event
- February 12, 2019
- Report Date
- November 25, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- JDI
- 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
THIS CASE WAS REOPENED TO CORRECT THE PREVIOUSLY REPORTED IMPLANTATION DATE. THIS ADDITIONAL INFORMATION DOES NOT CHANGE PREVIOUS MANUFACTURER'S ASSESSMENT OF THE CASE. ZIMMER CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: IMPLANT BREAKAGE NO LOT TRIGGER: NO SIMILAR INVESTIGATED EVENTS FOR THE SAME LOT NUMBER 2663200 HAVE BEEN FOUND. REVIEW OF EVENT DESCRIPTION: -IT WAS REPORTED THAT THE RIGHT HIP HAD TO BE REVISED BECAUSE THE SHAFT BROKE. THE IMPLANTATION WAS DONE IN 2014 AND THE REVISION ON (B)(6) 2019. REVIEW OF RECEIVED DATA: - A PDF FILE WITH SCANS OF PAPER COPIES OF X-RAYS WAS RECEIVED. UNDER EACH X-RAY THERE IS A HANDWRITTEN DATE. (B)(6) 2014: AP VIEW THE AP VIEW SHOWS A CEMENTED STEM IMPLANTED IN THE RIGHT HIP. ALONG THE PROXIMAL HALF OF THE LATERAL SIDE OF THE STEM A RADIOLUCENT LINE IS VISIBLE BETWEEN THE STEM AND THE CEMENT MANTLE. BETWEEN THE LATTER AND THE CORTICAL BONE A GAP CAN BE RECOGNIZED. (B)(6) 2014: LAUENSTEIN VIEW OF THE RIGHT HIP JUST BELOW THE STEM¿S COLLAR SOME BONE CEMENT CAN BE SEEN ON THE ANTERIOR SIDE OF THE STEM. ANTERIOR TO THIS BONE CEMENT AND ALONG THE REST OF THE PROXIMAL HALF OF THE ANTERIOR SIDE OF THE STEM A RADIOLUCENT AREA CAN BE SEEN. (B)(6) 2014: AP VIEW A REVITAN STEM IS IMPLANTED IN THE RIGHT HIP. A RADIOLUCENT GAP CAN BE RECOGNIZED BETWEEN THE CORTICAL BONE AND THE MEDIAL AND LATERAL SIDE OF THE PROXIMAL STEM PART WHICH EXTENDS SLIGHTLY TO THE PROXIMAL REGION OF THE DISTAL STEM PART. (B)(6) 2014: LAUENSTEIN VIEW OF THE RIGHT HIP ALONG THE CORTICAL BONE AND THE ANTERIOR SIDE OF THE PROXIMAL STEM PART THERE IS A RADIOLUCENT GAP VISIBLE. THE LATTER EXTENDS SLIGHTLY TO THE PROXIMAL REGION OF THE DISTAL STEM PART. IN THE PROXIMAL REGION OF THE FEMUR JUST ABOVE THE TROCHANTER MINOR AN AREA WITH SCLEROSIS IS SEEN. (B)(6) 2014: AP VIEW AS THERE IS A DIFFERENCE IN BRIGHTNESS AND CONTRAST COMPARED WITH THE PREVIOUS AP VIEW THE RADIOLUCENT GAP BETWEEN THE CORTICAL BONE AND THE MEDIAL AND LATERAL SIDE OF THE PROXIMAL STEM PART CANNOT BE RECOGNIZED. (B)(6) 2016: AP VIEW THE X-RAY HAS A BETTER QUALITY COMPARED WITH THE PREVIOUS STUDY DATES. A GAP IS VISIBLE ALONG THE MEDIAL AND LATERAL SIDE OF THE PROXIMAL STEM PART WHICH IS BORDERED ON THE BONE SIDE BY A SCLEROTIC LINE. (B)(6) 2016: LAUENSTEIN VIEW OF THE RIGHT HIP THE X-RAY HAS A BETTER QUALITY COMPARED WITH THE PREVIOUS STUDY DATES. ALONG THE ANTERIOR AND POSTERIOR SIDE OF THE PROXIMAL STEM PART THERE IS A RADIOLUCENT GAP VISIBLE WHICH IS BORDERED ON THE BONE SIDE BY SCLEROSIS. (B)(6)2018: AP VIEW COMPARED WITH THE PREVIOUS STUDY DATE IT CAN BE OBSERVED THAT THE PROXIMAL PART OF THE STEM IS SLIGHTLY TILTED TO THE MEDIAL SIDE. THERE ARE NO OBVIOUS CHANGES REGARDING THE BONE SITUATION AROUND THE PROXIMAL STEM PART. - REVIEW SURGICAL REPORTS IMPLANTATION REPORT OF (B)(6)2014 CLINICAL DIAGNOSIS: LOOSENING OF THE RIGHT TOTAL HIP PROSTHESIS (THP). OPERATIVE DIAGNOSIS: LOOSENING OF THE RIGHT THP. SLIGHT POLYETHYLENE WEAR IN THE REGION OF THE INLAY. PROCEDURE: THERE IS RADIOLOGICALLY PROVEN LOOSENING OF THE STEM AFTER A TOTAL ENDOPROSTHESIS ABOUT 8 YEARS AGO. PREOPERATIVE PUNCTURE HAD NO BACTERIOLOGICAL FINDINGS. THE INCISION IS MADE IN THE AREA OF THE OLD SCAR. EXTENSIVE DEBRIDEMENT AND COMPLETE CAPSULECTOMY IS MADE. THE HIP JOINT IS DISLOCATED AND THE STEM IS EXPOSED. THE PROXIMAL CEMENT IS GRADUALLY REMOVED. THE STEM IS CRASS LOOSENED AND CAN BE EASILY REMOVED. IN THE FEMORAL CANAL THERE ARE ADHERENT CEMENT PARTS THAT CAN BE REMOVED WITH GREAT EFFORT BY BREAKING THEM IN SMALL FRAGMENTS. FINALLY, THE TIP OF THE CEMENT IS PIERCED, THE DRILL HOLE IS WIDENED AND THEN THE FEMUR IS CLEANED WITH A REVERSING CHISEL. EXTENSIVE RINSING, RENEWED DEBRIDEMENT AND TAKING OF SAMPLES FROM THE FEMORAL CANAL FOR BACTERIOLOGICAL TESTING ARE PERFORMED. THE CUP IS EXPOSED AND FURTHER DEBRIDEMENT IS MADE. THE POLYETHYLENE INSERT IS REMOVED USING A SCREW. THE CUP IS COMPLETELY FIRM. THEREFORE, A NEW POLYETHYLENE INSERT IS INTRODUCED. THE OLD INSERT SHOWS SLIGHT WEAR MARKS. THE FEMUR IS EXPOSED AND REAMED FIRST TO THE REVITAN SIZE 14-140. INTRAOPERATIVE RADIOGRAPHIC CHECK IS MADE. THE TIP OF THE STEM IS APPROXIMATELY AT THE LEVEL OF THE PREVIOUSLY LOOSENED PROSTHETIC TIP. THEREFORE IT IS DECIDED TO INSERT A REVITAN STEM SIZE 200. THIS HAS ALSO A DIAMETER OF 14 MM. NEW RADIOGRAPHIC CHECK IS MADE. THE DIAMETER IS TOO SMALL, THEREFORE USING A SHORT 16 MM RASP, THE DIAMETER IS EXTENDED FOR A 16-200 MM STEM. RADIOGRAPHIC CHECK IS PERFORMED AGAIN AFTER REDUCTION WITH A TRIAL PART. THERE IS A SECURE FIT AND NO DISLOCATION TENDENCY. TAKING INTO CONSIDERATION THE ANTICURVATURE AND THE PREOPERATIVE PLANNING A CURVED 200 MM LONG, 16 MM DIAMETER REVITAN STEM IS INSERTED. A PROXIMAL PART SIZE 75 MM IS PLACED. AFTER THE TRIAL REDUCTION AND RADIOGRAPHIC CHECK A FINAL CERAMIC HEAD, SIZE L, IS IMPLANTED. THERE IS NO DISLOCATION TENDENCY. A REDON-DRAINAGE IS INSERTED AND THE WOUND IS CLOSED. REVISION REPORT OF (B)(6) 2019 PARTICULARITIES: INCREASED LEG SHORTENING ON THE RIGHT SIDE WHERE THERE IS A REVITAN STEM IMPLANTED WHICH IS BROKEN AT THE CONNECTION PIN. THE PATIENT IS NOW SUFFERING A LOT OF PAIN. PROCEDURE: THE HIP JOINT IS OPENED THROUGH THE OLD INCISION WHICH IS EXTENDED TO DISTAL AND PROXIMAL. SAMPLES ARE TAKEN FROM THE JOINT FOR MICROBIOLOGICAL TESTING. A 18 CM LONG LATERAL OSTEOTOMY IS PERFORMED, BUT THE TROCHANTER MAJOR FRAGMENT REMAINS COMPLETELY IN-SITU. WITH THE ADHERENT GLUTEUS MEDIUS THE BONE FLAP IS MOBILIZED TO THE VENTRAL SIDE AND SEVERED. SUBSEQUENTLY THE HIP JOINT CAN BE CAREFULLY DISLOCATED WHEREBY THE BROKEN PROXIMAL PART CAN BE EASILY REMOVED. WITH THE HELP OF A DRILL IT IS SUCCEEDED TO MAKE A HOLE DIRECTLY AT THE TRANSITION FROM THE THICK TO THE THINNER PORTION OF THE STEM. THE LATTER IS FIRMLY FIXED. IN ADDITION, RELEASE OF THE REMAINING PROSTHESIS FROM THE CORTICAL BONE IS MADE WITH FINE CHISELS BOTH ANTERIORLY AND POSTERIORLY. A CERCLAGE IS INSTALLED DISTALLY TO THE OSTEOTOMY TO AVOID DAMAGE TO THE BONE. USING A PUNCH THE STEM IS REMOVED WITHOUT BONE DAMAGE. THE MEDULLARY CANAL IS CURETTED AND SAMPLES ARE TAKEN FOR MICROBIOLOGICAL TESTING. THE FURTHER STEPS IN THE SURGICAL REPORT DESCRIBE THE IMPLANTATION OF A MP STEM AND A COCRMO HEAD. - PRODUCT STICKERS: SCAN COPIES OF TWO PAGES WITH AFFIXED PRODUCT STICKERS WERE RECEIVED. BOTH PAGES ARE UNDATED. ON THE FIRST PAGE, NEXT TO THE IMPLANTS ALREADY MENTIONED IN THIS REPORT, THE STICKER OF A PE - INSERT FOR EL - CUP 0° 32 MM WITH REF. NO. 50756 AND LOT NO. S5939, FROM ENDOPLANT GMBH, MARL, GERMANY, IS AFFIXED. ON THE SECOND PAGE THERE ARE SIMILAR STICKERS AS ON THE FIRST PAGE PLUS ADDITIONAL STICKERS OF PROBABLY INSTRUMENTATION AND CONSUMABLES USED DURING THE SURGERY. DEVICES ANALYSIS - VISUAL EXAMINATION: 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 FRACTURE SURFACES SHOW A FATIGUE FRACTURE STARTING FROM THE ANTEROLATERAL SIDE. THE MEDIAL END OF THE FRACTURE SURFACES IS POLISHED TO A SHINE WHILE ON THE LATERAL SIDE SOME BLACKISH DEPOSITS CAN BE SEEN. THE EDGES OF THE PROXIMAL FRACTURE SURFACE ARE PARTIALLY POLISHED AND DEFORMED. ON THE DISTAL FRACTURE SURFACE FEW SCRATCHES CAN BE SEEN. MACROSCOPICALLY, AS FAR AS VISIBLE, NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE WERE FOUND ON THE FRACTURE SURFACES. ON THE PROXIMAL PART OF THE REVITAN STEM SEVERAL SCRATCHES AND NICKS CAN BE OBSERVED. THESE DERIVED MOST PROBABLY FROM THE REVISION SURGERY. THERE ARE HARDLY ANY SIGNS OF BONE ONGROWTH ON THE ANCHORING SURFACE OF THE PROXIMAL STEM PART. THERE IS AN AREA WITH SHORT FINE HORIZONTAL POLISHED LINES ON THE MEDIAL SIDE OF THE PROXIMAL STEM PART EXTENDING SLIGHTLY TO THE POSTERIOR SIDE. SMALL POLISHED AREAS CAN BE NOTICED ON THE POSTERIOR SIDE OF THE MEDIAL NOSE AS WELL AS ON THE ANTERIOR SIDE OF THE LATERAL NOSE. ON THE PROXIMAL FRACTURE PART OF THE CONNECTION PIN THERE IS AN ALMOST CIRCUMFERENTIAL STRIPE REVEALING SURFACE CHANGES ADJACENT TO THE FRACTURE SURFACE. CLOSER INSPECTION OF THE STRIPE WITH A LOW POWER MICROSCOPE (LEICA MZ16 A) REVEALED POLISHING, SMEARED MATERIAL, FRETTING AND CORROSION. ADJACENT TO THE STRIPE JOINS THE ORIGINAL SURFACE FOLLOWED BY THE BLASTED AREA. ON THE DISTAL PART OF THE REVITAN STEM BONE ATTACHMENTS ARE VISIBLE. REMOVAL DAMAGE IN THE FORM OF SCRATCHES AND DRILL MARKS CAN BE RECOGNIZED ON THE ANCHORING SURFACE. SLIGHT WORN AREAS ARE SEEN ON THE LATERAL SIDE OF THE ANTERIOR NOSE AND ON THE MEDIAL SIDE OF THE POSTERIOR NOSE. THE INSIDE OF THE STEM BODY IS SLIGHTLY WORN LATERALLY. THESE WORN AREAS DERIVED MOST PROBABLY FROM CONTACT BETWEEN THE PARTS AFTER THE FRACTURE. IN THE AS-RECEIVED CONDITION THE SULOX HEAD AND THE PROXIMAL PART OF THE REVITAN STEM WERE STILL ASSEMBLED. FOR FURTHER INVESTIGATION THE PARTS WERE DISASSEMBLED. BEFORE THE DISASSEMBLY THE STEM TO HEAD POSITION WAS MARKED. THE HEAD TAPER SHOWS THE COMMONLY OBSERVED MATERIAL TRANSFER FROM THE STEM TAPER INDICATING A PROPER FIXATION OF THE HEAD ON THE STEM AND THE MATERIAL TRACK PROBABLY FROM ITS REMOVAL. SOME METALLIC SMEARING CAN BE NOTICED ON THE BOTTOM BEVEL OF THE HEAD. REVIEW OF PRODUCT DOCUMENTATION - ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. - SURGICAL TECHNIQUE: THE SURGICAL TECHNIQUE DESCRIBES THE CORRECT IMPLANTATION TECHNIQUE. THE SURGICAL APPROACHES AND OSTEOTOMIES ARE EXPLAINED. CONCLUSION SUMMARY: ACCORDING TO THE RECEIVED DOCUMENTATION, ON (B)(6) 2014 THE PATIENT HAD A REVISION OF THE RIGHT HIP PROSTHESIS DUE TO LOOSENING OF THE CEMENTED STEM. DURING THIS SURGERY A REVITAN STEM WAS IMPLANTED. BASED ON THE X-RAYS AT HAND WHICH WERE TAKEN JUST AFTER THE SURGERY, RADIOLUCENT GAPS WERE OBSERVED BETWEEN THE MEDIAL, LATERAL AND ANTERIOR SIDE OF THE PROXIMAL STEM PART AND THE CORTICAL BONE. THE X-RAY FOLLOW-UP SHOWS THAT THIS SITUATION DID NOT CHANGE DURING THE TIME IN VIVO OF THE REVITAN STEM. ON (B)(6) 2019 THE STEM WAS REVISED BECAUSE OF ITS FRACTURE. THE LATTER OCCURRED DUE TO FATIGUE IN THE NON-BLASTED AREA OF THE CONNECTION PIN SOME MILLIMETERS BELOW THE PROXIMAL END OF THE DISTAL PART. THE FRACTURE STARTED ON THE ANTEROLATERAL SIDE OF THE PIN. 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 THESE SURFACE CHANGES 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. THIS IS IN ALIGNMENT WITH THE X-RAYS AT HAND AND THE REVISION REPORT STATING THAT THE PROXIMAL PART CAN BE EASILY REMOVED. FURTHER, ON THE PROXIMAL PART OF THE REVITAN STEM AN AREA WITH FINE HORIZONTAL POLISHED LINES WAS OBSERVED ON ITS ANTEROMEDIAL SIDE. THIS COULD PROBABLY INDICATE MOVEMENTS BETWEEN THE PART AND THE SURROUNDINGS. IT IS UNKNOWN IF THIS AREA EXISTED ALREADY BEFORE THE START OF THE FRACTURE AND IS ASSOCIATED WITH IT OR DEVELOPED EXCLUSIVELY AS A CONCOMITANT. BASED ON THE ABOVE DESCRIBED FINDINGS, THE PROXIMAL BONE SUPPORT OF THE REVITAN STEM IMMEDIATELY AFTER IMPLANTATION SURGERY AND DURING THE TIME IN VIVO CAN BE INTERPRETED AS SUBOPTIMAL. THIS IN COMBINATION WITH OTHER FACTORS, E.G. THE PATIENT¿S OVERWEIGHT AND THE SURFACE CHANGES OBSERVED ON THE CONNECTION PIN MAY HAVE CONTRIBUTED TO THE FRACTURE. IT IS UNKNOWN TO WHICH EXTENT EACH FACTOR HAD AN INFLUENCE ON THE SEQUENCE OF EVENTS FINALLY RESULTING IN THE FATIGUE FRACTURE OF THE STEM AND IF THERE WERE OTHER INFLUENCING FACTORS. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). CORRECTIVE AND/OR PREVENTIVE ACTIONS HAVE BEEN INITIATED TO PREVENT REOCCURRENCE OF POTENTIAL PIN BREAKAGES OF THE REVITAN REVISION HIP SYSTEM IN THE FUTURE. ZIMMER GMBH DECIDED TO INITIATE A FIELD ACTION IN ORDER TO PROACTIVELY INFORM THE SURGEONS ABOUT HIGH RISK PATIENTS AS THEY MIGHT NOT BE AWARE OF THE EXPLICIT WARNING IN THE IFU. THE ACTION WAS INITIATED ON (B)(6) 2017. AS THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, THE USA/FDA IS NOT AFFECTED FROM THIS NOTIFICATION. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATE - ITEM# 0100402075, LOT# 2737481, REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 75, TAPER 12/14 - ITEM# 173207, LOT# 2733071, SULOX, HEAD, L, 32/+3.5, TAPER 12/14. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
NO EVENT UPDATE.
NO EVENT UPDATE.
PLEASE REFER TO REPORT 0009613350 - 2019 - 00120.
CONCOMITANT MEDICAL PRODUCTS: ITEM# 0100402075, LOT# 2737481, REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 75, TAPER 12/14. ITEM# 173207, LOT# UNKNOWN, SULOX, HEAD, L, 32/+3.5, TAPER 12/14. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. X-RAYS AND SURGERY PROTOCOL WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).
IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY FOUR YEARS POST IMPLANTATION DUE TO IMPLANT FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205179 | REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/200 | N/A | JDI | ZIMMER GMBH | N/A | 2663200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Hospitalization| R |