M2A-MAGNUM MOD HD SZ 46MM 46MM
Report
- Report Number
- 0001825034-2023-02806
- Event Type
- Injury
- Date Received
- December 6, 2023
- Date of Event
- July 27, 2023
- Report Date
- November 15, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWA
- PMA / PMN Number
- K042037
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- 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/CORRECTED: UPDATED: G3; H2; H3; H4; H6 H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. COMPLAINT CONFIRMED BASED ON EVALUATION OF THE PROVIDED MEDICAL RECORDS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED AND IDENTIFIED THE FOLLOWING: TRUNNION CLEAN AND INTACT, STEM STABLE. METALLOSIS TISSUE REMOVED FROM BEHIND THE ACETABULAR COMPONENT. SEVERE OSTEOLYSIS AND DEFECTS WITHIN THE ACETABULUM NOTED, HYDROSET APPLIED. ALL ZB COMPONENTS REMOVED, REPLACED WITH COMPETITOR PRODUCTS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS UNKNOWN IF THE OFF-LABEL USAGE WITH A COMPETITOR STEM CAUSED OR CONTRIBUTED TO THE EVENT. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D9; G3; H3. ONE CUP LOT# 607640, HEAD LOT# 983530, AND AN INSERT WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE CUP HAS DAMAGE TO THE POROUS COATING ALONG WITH CIRCULAR INDENTATION INSIDE OF THE INNER RADIUS. THE RETURNED HEAD HAS MULTIPLE WEAR LINES AND SCUFFING ON THE OUTER RADIUS. THE INSERT IS INSTALLED IN THE HEAD AND COULD NOT BE REMOVED FOR FURTHER EVALUATION. THE ROOT CAUSE IS UNCHANGED. EVENT IS CONFIRMED VIA RETURNED PRODUCT. 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.
(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 02805, 0001825034 - 2023 - 02807. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY THIRTEEN YEARS POST-IMPLANTATION DUE TO METALLOSIS. DURING THE REVISION, THE COMPETITOR STEM WAS FOUND STABLE AND WITHOUT COMPLICATIONS. WHEN THE ACETABULAR SHELL WAS REMOVED, METALLOSIS TISSUE WAS DEBRIDED, AND OSTEOLYTIC DEFECTS WERE FILLED WITH GRAFTING. THE ACETABULAR COMPONENTS WERE REPLACED WITH COMPETITOR PRODUCTS WITHOUT COMPLICATIONS. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220813 | M2A-MAGNUM MOD HD SZ 46MM 46MM | PROSTHESIS, HIP | KWA | ZIMMER BIOMET, INC. | N/A | 983530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H |