FDA Adverse Event
Injury
Summary report: N
M2A-MAGNUM 42-50MM TPR INSRT-3
MDR report key: 23862385
·
Received December 22, 2025
Report
- Report Number
- 0001825034-2025-04101
- Event Type
- Injury
- Date Received
- December 22, 2025
- Date of Event
- May 25, 2017
- Report Date
- May 1, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K101336
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4) D10: CAT# X180310 LOT# 676580 BI-METRIC/X POR NC 10X130. G2: FOREIGN - EVENT OCCURRED IN CANADA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 9 YEARS LATER DUE TO PAINFUL METAL-ON-METAL. DURING THE REVISION SLIGHT WEAR WAS NOTED ON THE TRUNNION AND CAPSULE FRAGMENTS WERE REMOVED FROM THE ACETABULUM. THE STEM WAS RETAINED ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238471 | M2A-MAGNUM 42-50MM TPR INSRT-3 | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | LPH | ZIMMER BIOMET, INC. | 676580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| R | SEE H11 NARRATIVE |