32MM M2A MOD HEAD -6MM NK
Report
- Report Number
- 0001825034-2018-09361
- Event Type
- Injury
- Date Received
- October 5, 2018
- Date of Event
- September 22, 2015
- Report Date
- March 18, 2019
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWY
- PMA / PMN Number
- K003363
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 11-163667 ¿ M2A MODULE HEAD ¿ 816120; 15-103684 ¿ M2A 2-HOLE SHELL ¿ 121150; 103205 ¿ TAPERLOC FEMORAL STEM ¿ 531360; 103534 ¿ TI LOW PROFILE SCREW - 488330. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.
IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO PAIN AND METALLOSIS. SURGEON OBSERVED AMOUNTS OF BLACKISH TISSUE IN THE HIP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO METALLOSIS, PAIN, OSTEOLYSIS, IMPLANT WEAR, AND ELEVATED METAL ION LEVELS. DURING THE SURGERY, BLACKISH TISSUE CONSISTENT WITH METALLOSIS OF THE HIP WAS FOUND. THERE WAS ALSO A LITTLE BIT OF DESTRUCTION AND OSTEOLYSIS OF THE BONE AROUND THE COMPONENTS AND A LARGE AMOUNT OF WEAR AROUND THE ACETABULAR COMPONENT.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO LOCATION OF DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09360.
IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO PAIN AND METALLOSIS. SURGEON OBSERVED AMOUNTS OF BLACKISH TISSUE IN THE HIP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 778455 | 32MM M2A MOD HEAD -6MM NK | PROSTHESIS, HIP | KWY | ZIMMER BIOMET, INC. | N/A | 816120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | UNKNOWN CUP| UNKNOWN LINER| UNKNOWN STEM| UNKNOWN CUP| UNKNOWN LINER| UNKNOWN STEM |