ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14
Report
- Report Number
- 0009613350-2018-00405
- Event Type
- Injury
- Date Received
- March 29, 2018
- Date of Event
- October 1, 2015
- Report Date
- September 12, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. THE MISSING INFORMATION WAS REQUESTED AT COMPLAINANT THE LATEST ONE ON MARCH 29, 2018 BUT WAS NOT AVAILABLE. THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E REF# 2839, ALLOCLASSIC ZWEYMULLER HIPSTEM, K030373) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PERIPROSTHETIC BONE FRACTURE REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH AN ALLOCLASSIC VARIALL STEM AND EXPERIENCED A PERIPROSTHETIC FEMUR FRACTURE 6 WEEKS POST OP AND WAS SUBSEQUENTLY REVISED. DURING REVISION SURGERY THE BIOLOX CERAMIC HEAD WAS EXPLANTED AS WELL. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS; ACCORDING TO THE INFORMATION RECEIVED, THE DEVICES WERE DISCARDED AT THE HOSPITAL. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. THE SURGICAL TECHNIQUE: LIT.NO. 06.00671.012X¿ ED. 07/2006 ZHUB WAS REVIEWED. ROOT CAUSE ANALYSIS; ROOT CAUSE DETERMINATION USING RMW: ASEPTIC LOOSENING OF STEM, BONE FRACTURE DUE TO INSUFFICIENT PRIMARY STABILITY DUE TO DESIGN = NOT POSSIBLE - A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. IMPLANT BREAKAGE, BONE FRACTURE DUE TO WRONG PLANNING TEMPLATE USED / MISINTERPRETATION OF THE X-RAY TEMPLATES REGARDING CENTRE OF ROTATION/LEG LENGTH/OFFSET. = POSSIBLE, NO SURGICAL REPORTS AND NO X-RAYS FOR REVIEW WERE RECEIVED. THEREFORE THIS CAUSE CANNOT BE EXCLUDED. SINCE THE REPORTED FEMORAL BONE FRACTURE IS NOT RELATED TO THE BIOLOX HEAD, NO ROOT CAUSE DETERMINATION USING SAP RMW FOR THIS DEVICE WAS DONE. CONCLUSION SUMMARY: IT IS REPORTED THAT A PATIENT EXPERIENCED A PERIPROSTHETIC FEMUR FRACTURE AROUND 6 WEEKS POST OP AND WAS SUBSEQUENTLY REVISED. 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. POSSIBLE ROOT CAUSE FOR THE REPORTED BONE FRACTURE COULD BE PREOPERATIVE PLANNING PRE-OPERATIVE PLANNING WAS NOT ACCORDING TO ZB RECOMMENDATION DESCRIBED IN THE SURGICAL TECHNIQUE. HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. 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 SIX WEEKS POST IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
CONCOMITANT MEDICAL PRODUCTS: UNKNOWN BIOLOX HEAD, REF# UNKNOWN, LOT# UNKNOWN. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00406. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO UNKNOWN REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226181 | ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14 | UNKNOWN | KWA | ZIMMER GMBH | N/A | 2780149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R | BIOLOX HEAD, ITEM# 00877503204, LOT# 2791338 |