BIOLOX DELTA CERAMIC TAPER LINER, SIZE FF
Report
- Report Number
- 0009613350-2023-00489
- Event Type
- Injury
- Date Received
- August 23, 2023
- Date of Event
- July 26, 2023
- Report Date
- November 22, 2023
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- LZO
- UDI-DI
- 00889024431577
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, B4, B5, D10, G3, G6, H1, H2, H10. D10 - BREXIS SHORT STEM SIZE 2 STD ITEM# (B)(4) LOT#20070875. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). D10 ¿ BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14 ITEM#00-8775-028-02 LOT#3123270; ALLOFIT IT ALLOCLASSIC, SHELL FOR ACETABULUM, UNCEMENTED, 46/FF ITEM#00-8755-046-00 LOT#2930655. G2 ¿ FOREIGN ¿ GERMANY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00488, 0009613350-2023-00490. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THE BIOLOX HEAD, THE BIOLOX LINER AND THE ALLOFIT CUP WERE RETURNED FOR INVESTIGATION; OF NOTE, THE LINER AND THE CUP ARE STILL ASSEMBLED. THE OUTER SURFACE OF THE CUP SHOWS SIGN OF BONE ONROWTH. THE FLAT RIM OF THE CUP SHOWS SOME SCRATCHES. THE LINER SHOWS SOME METAL TRANSFER ON THE ARTICULATING SURFACE, ON THE EDGE BETWEEN THE FLAT RIM AND THE ARTICULATING SURFACE AND ON THE FLAT RIM ITSELF. THE HEAD SHOWS METAL TRANSFER ON THE ARTICULATING SURFACE, ESPECIALLY ON ONE SIDE. THE HEAD TAPER SHOWS CIRCULAR AND PARALLEL METAL TRANSFERS, TYPICAL SEATING PATTERNS OF THE STEM TAPER IN THE HEAD. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICES ARE USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO CORRECTIVE, PREVENTIVE OR FIELD ACTION WAS TAKEN FOLLOWING THE INVESTIGATION OF THIS EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00488, 0009613350-2023-00490. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISLOCATION, NINE (9) MONTHS THIRTEEN (13) DAYS AFTER INITIAL HIP ARTHROPLASTY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1524957 | BIOLOX DELTA CERAMIC TAPER LINER, SIZE FF | HIP PROTHESIS | LZO | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 2933863 | 00889024431577 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention| H | SEE H10 NARRATIVE.| SEE H10 NARRATIVE. |