M2A-MAGNUM PF CUP 54ODX48ID
Report
- Report Number
- 0001825034-2025-02094
- Event Type
- Injury
- Date Received
- July 15, 2025
- Report Date
- November 18, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K101336
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
(B)(4). D10: 11-103205 TAPERLOC POR LAT FMRL 11X142 246400, 157448 M2A-MAGNUM MOD HD SZ 48MM 682040, 139254 M2A-MAGNUM 42-50MM TPR INSRT-3 827890. G2: FOREIGN: CANADA. 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 AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H3, H4, H6, H10 . NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY. LEGAL COUNSEL IS REPORTING PATIENT HAS FILED AN UNKNOWN ALLEGATION. NO REVISION HAS BEEN REPORTED AT THIS TIME.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1771747 | M2A-MAGNUM PF CUP 54ODX48ID | PROSTHESIS, HIPS | LPH | ZIMMER BIOMET, INC. | N/A | 308640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | SEE H11 NARRATIVE. |