M2A-MAGNUM PF CUP 52ODX46ID
Report
- Report Number
- 0001825034-2018-09578
- Event Type
- Injury
- Date Received
- October 9, 2018
- Date of Event
- August 1, 2017
- Report Date
- March 23, 2021
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWA
- PMA / PMN Number
- PK042037
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS INDICATE THE FOLLOWING: DIAGNOSIS: S/P MOM LEFT THA WITH ACETABULAR OSTEOLYSIS AND IMPENDING LOOSENING SYNOVITIS NOTED WITHOUT METALLOSIS PSEUDOCAPSULE NOTED WITH CLEAR FLUID, NO SIGN OF INFECTION SEVERE SUPERIOR OSTEOLYSIS NOTED WITHIN THE ACETABULUM, CUP EASILY REMOVED. SEVERE OSTEOLYSIS OF BONE SUPERIORLY AND POSTERIORLY, AGAIN WITHOUT METALLOSIS. SHELL AND FEMORAL HEAD REPLACED WITHOUT COMPLICATION. 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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. COMPLAINT SAMPLE WAS RETURNED AND EVALUATED AGAINST THE REPORTED EVENT. VISUAL INSPECTION OF THE RETURNED CUP SHOWED THAT THE CUP HAD BIO-DEBRIS ON THE OUTER RADIUS AND THERE WAS SCRATCHING ON THE INNER RADIUS. ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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 UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.
NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. MEDICAL DEVICES: ITEM NUMBER: 192512, ITEM NAME: ECHO POR FEM RED LAT NC 12X140, LOT #: 700100; ITEM NUMBER: 157446, ITEM NAME: M2A-MAGNUM MOD HD SZ 46MM, LOT #: 395880; ITEM NUMBER: 139259, ITEM NAME:M2A MAGNUM 42-50M TPR INSRT +6, LOT #: 615520. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09594 . THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 6 YEARS POST-IMPLANTATION DUE TO OSTEOLYSIS, ACETABULAR LOOSENING AND METAL POISONING. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 789050 | M2A-MAGNUM PF CUP 52ODX46ID | PROSTHESIS, HIP | KWA | ZIMMER BIOMET, INC. | N/A | 325660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |