M2A-MAGNUM PF CUP 54ODX48ID
Report
- Report Number
- 0001825034-2023-00522
- Event Type
- Injury
- Date Received
- March 9, 2023
- Date of Event
- May 24, 2022
- Report Date
- October 27, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K101336
- 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). CONCOMITANT MEDICAL PRODUCTS: CAT# 103207, LOT# 925550 ,TAPERLOC POR FMRL 13.5X147, CAT# 139256, LOT# 201480, M2A-MAGNUM 42-50 TPR INSRT STD. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 00523. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE SHELL HAS DEBRIS ON THE OD ALONG WITH SCUFFING TO THE INNER RADIUS. REVIEW OF THE DEVICE HISTORY RECORD(S) 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: MODERATELY ADVANCED OSTEOLYSIS AT THE ACETABULUM. MEDIAL DEFECT AS WELL AS ANTERIOR AND INFERIOR WALL DEFICIENCY WAS NOTED. PATIENT EXPERIENCING INCREASED PAIN. MRI REVEALS PSEUDOTUMOR AND SOME ADVERSE REACTION TO METAL DEBRIS. A DEFINITIVE ROOT CAUSE CANNOT 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) 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: MODERATELY ADVANCED OSTEOLYSIS AT THE ACETABULUM. MEDIAL DEFECT AS WELL AS ANTERIOR AND INFERIOR WALL DEFICIENCY WAS NOTED. PATIENT EXPERIENCING INCREASED PAIN. MRI REVEALS PSEUDOTUMOR AND SOME ADVERSE REACTION TO METAL DEBRIS. A DEFINITIVE ROOT CAUSE CANNOT 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 UNDERWENT RIGHT METAL-ON-METAL HIP ARTHROPLASTY THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY ELEVEN (11) YEARS LATER DUE TO METAL-ON-METAL RIGHT HIP. BOTH THE ACETABULAR AND FEMORAL COMPONENTS WERE REVISED. DURING THE REVISION, PSEUDOTUMOR AND SOME METAL DEBRIS WAS OBSERVED. MODERATE OSTEOLYSIS AT THE ACETABULUM WAS NOTED. IT WAS ALSO NOTED THAT A PORTION OF THE POROUS COATING OF THE CUP STAYED INTACT INFERIORLY. WHILE ATTEMPTING TO REMOVE THIS PORTION, THE INFERIOR PORTION OF THE ACETABULUM SUSTAINED A FRACTURE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1292693 | M2A-MAGNUM PF CUP 54ODX48ID | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 557630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| H |