EXAFIT STEM 4.1
Report
- Report Number
- 0009613350-2018-01184
- Event Type
- Injury
- Date Received
- December 6, 2018
- Date of Event
- October 25, 2018
- Report Date
- July 25, 2019
- Manufacturer
- ZIMMER 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
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. CONCOMITANT MEDICAL PRODUCTS ACCORDING D11: ITEM NAME: HD ALUMINE CONE 8/10 D28/+3.5, ITEM#: 15132807, LOT#: 4001242. ITEM NAME: NUCLEO PRSFT CDIOR C/CEJA28/58, ITEM#: 144012858, LOT#: UNKNOWN. ITEM NAME: COTILO PRESSFIT-HAK CEDIOR 58, ITEM#: 144100058, LOT#: N0829. DHR REVIEW: REF#: 01.06006.401. LOT#: 4000986. YIELD: 12. DELIVERED: 12. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: A TREND CONSIDERING EXAFIT BREAKAGE WAS PREVIOUSLY IDENTIFIED AND ADDRESSED IN DESIGN CHANGE. EVENT DESCRIPTION: ON (B)(6) 2018 FRACTURE OF AN EXAFIT STEM IMPLANTED ON (B)(6) 2004. THE PATIENT HAS TURNED HIS RIGHT LEG AND IT PRESENTED BRUTALLY A CRACK. THE X-RAYS SHOW A FRACTURE OF THE NECK OF THE STEM. REVIEW OF RECEIVED DATA: REVIEW OF X-RAY. REVIEW OF IMPLANTATION REPORT. REVIEW OF REVISION REPORT. EMERGENCY REPORT. DEVICES ANALYSIS: VISUAL EXAMINATION: THE EXAFIT STEM IS FRACTURED IN THE NECK REGION. THE FRACTURE OCCURRED APPROXIMATELY 20 MM BELOW THE PROXIMAL END. EXCEPT FOR SOME SCRATCHES AND PARTIAL POLISHING ALONG THE EDGE THE PROXIMAL FRACTURE SURFACE SEEMS TO BE IN THE ORIGINAL CONDITION. THE LATTER SHOWS A FATIGUE FRACTURE AND RESIDUAL FRACTURE. IN THE AREA OF THE FRACTURE ORIGIN SOME NICKS ARE VISIBLE. THE DISTAL FRACTURE SURFACE IS PARTIALLY POLISHED AND THE EDGE IS MOSTLY WORN. FROM THE STILL INTACT FRACTURE STRUCTURE AND THE LOCATION OF THE RESIDUAL FRACTURE IT CAN BE CONCLUDED THAT THE FRACTURE ORIGIN IS LOCATED ON THE LATERAL SIDE OF THE STEM. THE STEM TAPER SHOWS SIGNS OF FRETTING CORROSION. THE STEM NECK EXHIBITS SCRATCHES, SMEARED MATERIAL AND MARKS FROM THE USE OF AN ELECTROCAUTERY TOOL. ON AND DISTAL TO THE COLLAR OF THE STEM DAMAGE SUCH AS INDENTATIONS, FINE AND COARSE SCRATCHES, MOST PROBABLY DERIVING FROM THE REVISION SURGERY CAN BE OBSERVED. IN THE ANCHORING AREA SCRATCHES AND INDENTS CAN ALSO BE DETECTED THAT ARE ASSUMED TO DERIVE FROM THE REVISION SURGERY. UNDER CERTAIN LIGHT CONDITIONS, SLIGHTLY MATT AREAS CAN BE RECOGNIZED ON THE ANTEROLATERAL, POSTEROMEDIAL AND ANTEROMEDIAL EDGES OF THE STEM. INVESTIGATION OF THE SLIGHTLY MATT AREAS WITH THE MICROSCOPE REVEALED FINE SCRATCHES AND SMALL LINE- TO-DOT-SHAPED INDENTATIONS. ON THE TIP OF THE STEM AN AREA WITH CORROSION CAN BE RECOGNIZED. THE ANCHORING SIDE OF THE PRESS-FIT CEDIOR CUP EXHIBITS BONE ONGROWTH IN THE AREAS OF THE FINS AND IN THE POLE HOLE. SOME OF THE FINS ARE DAMAGED AND SLIGHT SCRATCHES AND INDENTS CAN ALSO BE SEEN. SOME SMALL BROWNISH SPOTS THAT MOST LIKELY DERIVE FROM AN ELECTROCAUTERY TOOL ARE VISIBLE IN AN AREA CLOSE TO THE RIM AND ON THE RIM. IN ONE AREA SOME POLISHING CAN BE OBSERVED. THE INSIDE OF THE CUP IS INCONSPICUOUS. THE PE KAPPA HOODED INSERT SHOWS A LARGE AREA OF ABRASION THAT COVERS ALMOST THE ENTIRE HOOD. AS A CONSEQUENCE THE MIDDLE OF THE HOOD IS MISSING. FURTHER THE RIM EXHIBITS SOME CUTS, SCRATCHES, INDENTS AND SOME SIGNS OF DELAMINATION. THERE ARE SOME CRACKS VISIBLE IN THE REMAINING HOODED AREA. THE ARTICULATION SURFACE IS POLISHED AND APPEARS SLIGHTLY YELLOWISH DISCOLORED. SOME DAMAGE CAN ALSO BE SEEN ON THE ARTICULATION SURFACE. THE ANCHORING SIDE OF THE INSERT IS PARTIALLY YELLOWISH DISCOLORED AND MIRRORS THE CONTOUR OF THE CUP. THE IMPRINTS OF THE HOLES ARRANGED IN ONE HALF OF THE BACKSIDE CAN BE RECOGNIZED. SOME AREAS APPEAR POLISHED TO A SHINE WHILE THE REMAINING SURFACE APPEARS MATT. CLOSER INSPECTION OF THE ANCHORING SIDE WITH A BINOCULAR REVEALED BACKSIDE CHANGES AROUND THE IMPRINTS AND ON THE VERTICAL OUTER SURFACE. THESE CHANGES CORRESPOND TO THE AREAS APPEARING POLISHED TO A SHINE. THE REMAINING SURFACE EXHIBITS ORIGINAL MACHINING LINES. DURING THE CLEANING PROCEDURE (AUTOCLAVE) THE CERAMIC HEAD FRACTURED INTO THREE FRAGMENTS. ALL OF THEM SHOW DIFFUSE SCRATCHES AROUND THE TAPER ENTRANCE. SOME BLACKISH DEPOSITS ADHERE IN THE TAPER REGION WHERE THE HEAD WAS IN CONTACT WITH THE STEM TAPER. SCANNING ELECTRON MICROSCOPIC EXAMINATION: THE PROXIMAL FRACTURE SURFACE WAS FURTHER INVESTIGATED USING A SCANNING ELECTRON MICROSCOPE. DUE TO THE SIZE OF THE STEM AND THE POSITION OF THE FRACTURE IT WAS NOT POSSIBLE TO FURTHER INVESTIGATE THE DISTAL FRACTURE SURFACE. AREAS WITH ORIGINAL FRACTURE STRUCTURE LOCATED CLOSE TO THE FRACTURE ORIGIN SHOW A FATIGUE STRUCTURE INCLUDING TYPICAL SECONDARY CRACKS. IN THE AREA OF THE FRACTURE ORIGIN SOME NICKS ARE VISIBLE. THEREFORE THE FRACTURE ORIGIN COULD NOT BE IDENTIFIED. HOWEVER BASED ON THE NICK¿S APPEARANCE IT IS ASSUMED THAT THEY OCCURRED AFTER THE FRACTURE, POSSIBLY MADE DURING REVISION SURGERY. FURTHER, THEY CAN ONLY BE FOUND ON THE PROXIMAL FRACTURE PART WHICH ALSO POINTS TO AN OCCURRENCE AFTER THE FRACTURE. TOWARDS THE END OF THE FRACTURE SURFACE A DIMPLE STRUCTURE IS VISIBLE WHICH IS TYPICAL FOR THE RESIDUAL FRACTURE. AS FAR AS VISIBLE NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE COULD BE FOUND ON THE FRACTURE SURFACE. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. / ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. CONCLUSION SUMMARY: AFTER MORE THAN 14 YEARS IN VIVO A FRACTURE OF THE EXAFIT STEM WAS DISCOVERED DURING AN EMERGENCY VISIT OF THE PATIENT. THE PATIENT HAD PAIN AND WAS UNABLE TO MOVE HIS LEG AFTER A FALL. THE STEM SHOWS A FATIGUE FRACTURE STARTING FROM THE LATERAL SIDE IN THE NECK REGION APPROXIMATELY 20 MM BELOW STEM TAPER'S FACE SURFACE. NEITHER ON THE FRACTURE SURFACE NOR ON THE LATERAL AREA OF THE STEM NECK SIGNS OF DEFECTS OR DAMAGE THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE COULD BE FOUND. HOWEVER, THE STEM NECK EXHIBITS SEVERAL TYPES OF DAMAGE IN THE FORM OF SCRATCHES, NICKS AND ELECTROCAUTERY DAMAGE WHICH ARE NOT POSSIBLE TO DETERMINE IF THEY OCCURRED BEFORE OR AFTER THE FRACTURE. WITH THE INVESTIGATIONS PERFORMED AND THE RECEIVED DOCUMENTATION A REASON OR CONTRIBUTING FACTORS FOR THE FRACTURE COULD NOT BE IDENTIFIED. INFORMATION ABOUT THE PATIENT¿S MEDICAL HISTORY, BMI AND LEVEL OF EXERCISE IS NOT AT HAND. IT REMAINS UNKNOWN IF THESE PATIENT FACTORS OR FURTHER OTHER FACTORS COULD HAVE CONTRIBUTED TO THE STEM FRACTURE. AS SEEN IN THE X-RAYS AT HAND, AFTER THE FRACTURE, THE DISTAL FRACTURE PART OF THE STEM RESTED ON THE INSERT'S RIM. THIS RESULTED IN THE LARGE ABRASION IN THE HOODED AREA, POLISHING ON THE CUP¿S RIM AS WELL AS WEAR AND POLISHING ON THE DISTAL FRACTURE SURFACE. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). 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).
INVESTIGATION RESULTS ARE NOW AVAILABLE.
THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. X-RAYS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 FOURTEEN YEARS AND SIX MONTHS 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 |
|---|---|---|---|---|---|---|---|
| 976407 | EXAFIT STEM 4.1 | NA | KWA | ZIMMER GMBH | N/A | 4000986 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |