TIGE PF LAT SANS CIMENT AVEC HA T7
Report
- Report Number
- 9613350-2016-00445
- Event Type
- Injury
- Date Received
- February 29, 2016
- Date of Event
- January 7, 2016
- Report Date
- January 9, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- PNA
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- MEDICAL ASSISTANT
Narratives
THE CASE WAS REOPENED AS THE DEVICE AND ADDITIONAL INFORMATION WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION WAS UPDATED ACCORDINGLY. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: STEM FRACTURE. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT SUMMARY: IT IS REPORTED THAT IT CAME TO A FRACTURE OF THE RIGHT THR WHILE WALKING UP THE STAIRS AT THE PATIENT¿S HOME ON (B)(6) 2016. AS A CONSEQUENCE THE THR HAD TO BE CHANGED. REVIEW OF RECEIVED DATA QUESTIONNAIRE PRE-ANESTHETIC WEIGHT: (B)(6), HEIGHT: 1.79 M. PATIENT MARKED WITH A CROSS THAT HE IS PRACTICING SPORT. SURGICAL REPORT (B)(6) 2004. BILATERAL COXARTHOSIS THA RIGHT, UNCEMENTED A POSTEROLATERAL APPROACH IS USED, THE HIP DISLOCATED AND THE NECK IS CUT. NOW THE ACETABULUM IS PREPARED USING REAMERS WITH GROWING DIAMETERS. AN UNCEMENTED FITEK SHELL OUTER Ø 56 IS IMPLANTED AND A METASUL INSERT WITH INNER Ø 32 IS PLACED. THEN THE FEMUR IS PREPARED USING REAMERS WITH GROWING DIAMETERS. A TRIAL REDUCTION IS PERFORMED AND A PF STEM LATERALISED WITHOUT CEMENT SIZE 7 WITH A METASUL HEAD Ø 32 M ARE PLACED. THE DEFINITIVE REDUCTION IS PERFORMED. THERE IS A GOOD STABILITY OF THE HIP. THE LEG LENGTHS ARE OBVIOUSLY EQUAL. ABUNDANT WASHING IS PERFORMED. IN THE REST OF THE REPORT THE WOUND CLOSURE IS DESCRIBED. RADIOLOGICAL REPORT PELVIS OVERVIEW X-RAYS OF THE LEFT HIP AXIAL A THR IS PLACED ON THE RIGHT HIP AND IS NORMAL FROM RADIOLOGICAL POINT OF VIEW. REMINDER: COXARTHOSIS LEFT EXTREMELY PROGRESSED. QUESTIONNAIRE PRE-ANESTHETIC DATE: (B)(6) 2016 WEIGHT: (B)(6), HEIGHT: 1.80 M. PATIENT MARKED WITH A CROSS THAT HE IS PRACTICING SPORT (GYM). SURGICAL REPORT (B)(6) 2016 (PART I.28 OF THE LEGAL DOSSIER) INDICATION 10 YEARS AGO THE PATIENT RECEIVED A THR RIGHT. THERE IS A SPONTANEOUS FRACTURE OF THE PROSTHESIS AT THE HEIGHT OF ITS NECK. THE INDICATION FOR A REVISION OF THE PROSTHESIS IS GIVEN. IT WAS DELAYED DUE TO THE OCCURRENCE OF ERYSIPELAS BETWEEN THE GROIN AND THE BUTTOCKS, BILATERAL. THE PATIENT WAS SEEN BY THE DERMATOLOGIST AND THE SKIN IS HEALED. THEREFORE, IT WAS DECIDED TO PERFORM THE REVISION TODAY. INTERVENTION: REVISION OF A THR RIGHT, CHANGE OF THE STEM, FEMOROTOMY, ZIMMER X4 CABLE CERCLAGE AND STEM PS LATERALISED SIZE 7 CEMENTED SURGERY: A POSTERIOR APPROACH AFTER MOORE IS USED. A CONSIDERABLE FIBROSIS IS RESECTED. THE PROXIMAL FEMUR IS FREED AND THE BROKEN STEM NECK WITH THE HEAD IS REMOVED. THE INTEGRITY OF THE CUP PROTECTED BY A COMPRESS WAS CHECKED. IT IS NOT POSSIBLE TO GRASP THE STEM AT ALL. GIVEN THE EXCELLENT FIXATION IT IS DIRECTLY DECIDED TO PERFORM A FEMOROTOMY WHICH ENDS SLIGHTLY ABOVE THE TIP OF THE STEM. THE BONE FLAP COULD BE REMOVED. IT IS NOT FRAGILE BECAUSE THE CORTICAL BONE IS VERY THICK. THE ZIMMER STEM LATERALISED SIZE 7 IS EXPOSED. THE SAW IS USED TO FREE THE STEM. THE REMOVAL OF THE STEM IS DIFFICULT BUT CAN BE REALISED FINALLY. THE BONE FLAP IS REDUCED WITH THE HELP OF 4 CABLES. IT IS TRIED TO ENTER THE REAMER FOR A REVISION STEM. THE CURVATURE OF THE FEMUR AND THE SIZE OF THE CORTICAL BONE DO NOT ALLOW USING THIS REVISION STEM. THEREFORE, IT IS DECIDED TO IMPLANT A CEMENTED STEM LATERALISED SIZE 7. IT IS ORIENTED LIKE THE PREVIOUS STEM AS WELL AS PLACED ON THE SAME HEIGHT. AFTER THE COMPLETE HARDENING OF THE CEMENT NUMEROUS FRAGMENTS OF THE CEMENT THAT PROTRUDE DUE TO THE FEMORAL OSTEOTOMY ARE REMOVED. A TRIAL REDUCTION WITH A HEAD OF THE SAME NECK LENGTH LIKE THE PREVIOUS IS PERFORMED. THERE IS A GOOD STABILITY. THE DEFINITE HEAD SIZE 32 IS PLACED AND THE PROSTHESIS IS REDUCED. THE REST OF THE REPORT DESCRIBES THE WOUND CLOSURE. DEVICES ANALYSIS: - VISUAL EXAMINATION: THE PF STEM SHOWS A FRACTURE IN THE TRANSITION ZONE BETWEEN STEM NECK AND SHOULDER. IN THIS AREA THE END OF THE RECTANGULAR IMPACTION HOLE IS LOCATED ON THE LATERAL SIDE. BOTH FRACTURE SURFACES ARE DAMAGED. THE FRACTURE SURFACES EXHIBIT A FATIGUE FRACTURE. THE FRACTURE ORIGIN IS LOCATED ON THE ANTERIOR EDGE OF THE MEDIAL END OF THE IMPACTION HOLE. THE FATIGUE FRACTURE PORTION AMOUNTS TO APPROXIMATELY 75% OF THE FRACTURE SURFACE. ON BOTH FRACTURE SURFACES A SMALL, DARK BLUE-GREY, PARTIAL CIRCLE CAN BE OBSERVED AT THE FRACTURE ORIGIN. THE SURFACE OF THE PROXIMAL FRACTURE PART EXHIBITS SEVERAL SPOT-LIKE DISCOLORATIONS AND FEW SCRATCHES. FEW SPOT-LIKE DISCOLORATIONS AS WELL AS SOME COARSE SCRATCHES CAN BE SEEN ON THE SURFACE OF THE DISTAL FRACTURE PART. THE POSTEROMEDIAL EDGE OF THE LATTER IS DAMAGED. THE LATERAL SURFACE OF THE STEM NECK SHOWS SCRATCHES, SMALL DENTS AND SOME SPOT-LIKE DISCOLORATIONS. ON THE SHOULDER OF THE STEM SPOT-LIKE DISCOLORATIONS AND SCRATCHES ARE VISIBLE. THERE IS A POLISHED APPEARING AREA ABOVE THE COATED AREA ON THE POSTERIOR STEM SIDE. THE ORIGIN OF THAT POLISHED APPEARING AREA IS UNKNOWN. IN THE COATED AREA OF THE STEM¿S ANCHORING SURFACE REMAINS OF HA COATING AND BONE ATTACHMENTS ARE PRESENT. ON THE STEM¿S ANCHORING SURFACE SEVERAL TOOL MARKS AND COARSE SCRATCHES CAN BE OBSERVED. THE METASUL HEAD SHOWS SCRATCHED AREAS CLOSE TO THE EQUATOR. THE HEAD SURFACE WAS INSPECTED UNDER A MICROSCOPE TYPE NIKON EPIPHOT ((B)(4)) AT 200-TIMES MAGNIFICATION WITH DIFFERENTIAL INTERFERENCE CONTRAST (DIC). CARBIDES, WHICH IN THE ORIGINAL SURFACE STATE PROTRUDED SLIGHTLY, CAN ONLY BE SEEN CLOSE TO AND IN THE EQUATOR REGION. AREAS WITH DIFFERENT DENSITY OF SCRATCHES ARE VISIBLE IN THE LOADED AREA. REVIEW OF PRODUCT DOCUMENTATION - THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY AFTER 12 YEARS IN VIVO THE PF STEM HAD TO BE REVISED DUE TO A FRACTURE IN THE TRANSITION ZONE BETWEEN STEM NECK AND SHOULDER. IN THIS REGION A RECTANGULAR IMPACTION HOLE IS LOCATED. THE FRACTURE ORIGIN IS LOCATED AT THE ANTERIOR EDGE OF THE MEDIAL END OF THE IMPACTION HOLE. THE FRACTURE OCCURRED DUE TO FATIGUE. ON BOTH FRACTURE SURFACES A SMALL, DARK BLUE-GREY, PARTIAL CIRCLE CAN BE OBSERVED AT THE FRACTURE ORIGIN. THIS PARTIAL CIRCLE DIFFERENTIATES BY COLOUR FROM THE OTHER SPOT-LIKE DISCOLORATIONS ON THE FRACTURE SURFACES. THE LATTER CAN PROBABLY BE ATTRIBUTED TO THE USE OF AN ELECTROSURGICAL INSTRUMENT (CAUTER) DURING REVISION SURGERY. HOWEVER, THIS IS NOT EXPLICITLY DESCRIBED IN THE SURGICAL REPORT. IN THE COATED AREA OF THE STEM BONE ATTACHMENTS CAN BE SEEN. THE TOOL MARKS AND COARSE SCRATCHES ON THE STEM¿S ANCHORING SURFACE CAN MOST POSSIBLY BE ASCRIBED TO DAMAGE FROM THE REVISION SURGERY, AS ACCORDING TO THE SURGICAL REPORT THE DISTAL FRACTURE PART WAS DIFFICULT TO REMOVE AND A FEMOROTOMY HAD TO BE PERFORMED. THESE FACTS INDICATE A GOOD FIXATION OF THE STEM IN THE BONE. THE ARTICULATION SURFACE OF THE METASUL HEAD DOES NOT SHOW CONSPICUOUS PHENOMENA. THE CLINICAL DOCUMENTS AT HAND (REPORT OF THE REVISION SURGERY, PRODUCT STICKERS) POINT OUT THAT THE METASUL INSERT OF THE CUP WAS NOT REVISED, BUT THE METASUL HEAD WAS REPLACED BY A COCR HEAD. THE COMBINATION OF A METASUL INSERT AND A COCR HEAD IS AN UNAUTHORIZED COMBINATION WHICH IS NOT RELEASED BY ZIMMER BIOMET (SEE WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM) AND MAY LEAD TO EFFECTS SUCH AS UNEXPECTED WEAR, POSSIBLE INCREASED METAL ION RELEASE ETC. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND IDENTIFIED. EVENT SUMMARY: IT WAS REPORTED THAT THE STEM WAS BROKEN WHEN THE PATIENT WENT UP THE STAIRS. ALL OTHER COMPONENTS WERE REVISED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ROOT CAUSE ANALYSIS: NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN THE APPROPRIATE DFMEA . THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, NEITHER THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE ACTUAL DEVICE IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (ALLOCLASSIC ZWEYMUELLER HIP STEM) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. 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'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED ON MAY 31, 2016 AND WAS ADDED TO THE CASE. THIS ADDITIONAL INFORMATION DOES NOT CHANGE PREVIOUS MANUFACTURER'S ASSESSMENT OF THE CASE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT IS REPORTED THAT A PATIENT WAS IMPLANTED A TIGE PF LAT SANS CIMENT AVEC HA T7 ON UNKNOWN DATE ON THE RIGHT SIDE AND WAS REVISED DUE TO BREAKAGE, AFTER UNKNOWN TIME IN VIVO ON UNKNOWN DATE. IT IS ALSO REPORTED, THAT THE BREAKAGE OF THE STEM OCCURRED ON (B)(6) 2016 WHILE PATIENT WENT UP THE STAIRS.
THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT HAS NOW BEEN REPORTED, THAT THE PATIENT WAS IMPLANTED A TIGE PF LAT SANS CIMENT AVEC HA T7 ON (B)(6) 2004. ON (B)(6) 2016 THE STEM BROKE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2016 DUE TO THE BREAKAGE OF THE STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124274 | TIGE PF LAT SANS CIMENT AVEC HA T7 | UNKNOWN | LZO | ZIMMER GMBH | N/A | 4000850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| R |