M2A-MAGNUM PF CUP 50ODX44ID
Report
- Report Number
- 0001825034-2025-00984
- Event Type
- Injury
- Date Received
- April 3, 2025
- Date of Event
- August 19, 2024
- Report Date
- February 16, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K101336
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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: D9; G3; H2; H6 TYPE OF INVESTIGATION. THE FOLLOWING SECTIONS WERE CORRECTED: H4. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE INNER SPHERICAL SURFACE IS SCRATCHED AND GOUGED. OUTER SPHERICAL SURFACE HAS EMBEDDED BIO DEBRIS. NO OTHER DAMAGE WAS NOTED. MODULAR HEAD WAS RETURNED WITH TAPER ADAPTER MATED. DEVICES SHOW WEAR FROM USE. NICKS, SCRATCHES, AND GOUGES ARE NOTED TO THE SPHERICAL SURFACE, BOTTOM, AND TAPER WALL OF BOTH DEVICES. NO OTHER DAMAGE WAS NOTED. BIO DEBRIS IS PRESENT ON THE DEVICE. 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). D10: 157444 M2A-MAGNUM MOD HD SZ 44MM 44MM 638040. 192511 ECHO POR FEM RED LAT NC 11X135 558790. 139256 M2A-MAGNUM 42-50 TPR INSRT STD 0/0MMT1 196690. PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. 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: D4, 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. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT HAD A RIGHT INITIAL THA. PATIENT LATER DEVELOPED HIP PAIN AND FOLLOW UP TESTS REVEALED ELEVATED METAL IONS WHERE CHROMIUM AND COBALT WERE HIGH. PATIENT HAD A HIP REVISION. INTRAOPERATIVE FINDINGS WERE CONSISTENT WITH METALLOSIS. DEEP TO THE FASCIA A MODERATE SEROMA WAS ENCOUNTERED WITH BROWNISH FLUID, THE TISSUES WERE SLIGHTLY HEMOSIDERIN STAINED. THE FLUID WAS EVACUATED AND ABNORMAL TISSUE DEBRIDED SHARPLY. THE FEMORAL HEAD WAS REMOVED WITH A TAMP. THE TRUNNION WAS NORMAL IN APPEARANCE. THE ACETABULAR COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS AND A NEW CUP PLACED. NO OTHER COMPLICATIONS WERE NOTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE MEDICAL RECORDS, THE COMPLAINT IS CONFIRMED. 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.
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED HIP PAIN AND THE WORK-UP REVEALED ELEVATED METAL ION LEVELS, INTRAOPERATIVE FINDINGS WERE CONSISTENT WITH METALLOSIS. THE PATIENT UNDERWENT REVISION OF THE HEAD AND ACETABULAR COMPONENT WITHOUT ANY KNOWN COMPLICATIONS. FURTHER DETAILS HAVE NOT BEEN PROVIDED.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 732337 | M2A-MAGNUM PF CUP 50ODX44ID | PROSTHESIS, HIPS | LPH | ZIMMER BIOMET, INC. | N/A | 388810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Hospitalization| R |