M2A 38MMX58MM CUP
Report
- Report Number
- 0001825034-2022-01385
- Event Type
- Injury
- Date Received
- June 13, 2022
- Date of Event
- January 13, 2015
- Report Date
- July 19, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWA
- PMA / PMN Number
- K011110
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 11-103209, LOT NUMBER:119590, BRAND NAME: TAPERLOC FEMORAL STEM; CATALOG NUMBER: RD118858, LOT NUMBER: 030790, BRAND NAME: M2A 38 MM CUP; CATALOG NUMBER: 11-173663, LOT NUMBER:241310, BRAND NAME:M2A HEAD. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT: 0001825034-2015-00433. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. LEFT SIDE FINDINGS: PATIENT HISTORY INCREASED PAIN, CLUNKING, AND ELEVATED COBALT AND CHROMIUM LEVELS AS REPORTED. NO INTEROP COMPLICATIONS WERE NOTED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE COULD NOT 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 THAT THE PATIENT WAS REVISED DUE TO DUE TO PAIN, CLUNKING, AND SIGNIFICANTLY ELEVATED COBALT AND CHROMIUM LEVELS APPROXIMATELY 11 YEARS POST IMPLANTATION. CORROSION AND OSTEOLYSIS WERE NOTED DURING THE PROCEDURE. MEDICAL RECORDS INDICATED THAT THERE WAS MINIMAL CLEAR JOINT FLUID PRESENT WITHOUT GRAY TINGE UPON ENTERING THE JOINT DURING THE REVISION PROCEDURE. THE FEMORAL COMPONENT WAS WELL-EMBEDDED IN THE BONE. THE TRUNNION WAS NOTED TO BE QUITE SHORT AND THERE WAS SIGNIFICANT BLACK FRETTING CORROSION VISIBLE BUT NO ACTUAL DAMAGE. THE HEAD SHOWED A SMALL AREA (MAYBE 10%) OF BURNISHING WITH A STRIPE ON THE SUPER EDGE. THERE WAS NO EVIDENCE OF TITANIUM METALLOSIS. FINALLY, THERE WAS MINIMAL BURNISHING IN THE SUPERIOR RIM OF THE ACETABULAR COMPONENT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1687367 | M2A 38MMX58MM CUP | PROSTHESIS, HIP | KWA | ZIMMER BIOMET, INC. | N/A | 030790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male | Required Intervention| H | SEE H10 NARRATIVE |