M2A-MAGNUM PF CUP 50ODX44ID
Report
- Report Number
- 0001825034-2022-02486
- Event Type
- Injury
- Date Received
- November 4, 2022
- Date of Event
- January 8, 2020
- Report Date
- December 12, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K101336
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN-UNKNOWN 44MM MALLORY HEAD-UNKNOWN, UNKNOWN-UNKNOWN STEM-UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, ASSOCIATED REPORTS: 0001825034 - 2022 - 02487, 0001825034 - 2022 - 02488. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. 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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D2; G3; G4; H2; H3; H6 D2 DEVICE PRODUCT CODE CORRECTED. G4 PMA/510(K) NUMBER CORRECTED. REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS AND RADIOGRAPHS REVIEWED BY A HEALTH CARE PROFESSIONAL. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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.
D10: 157444-M2A-MAGNUM MOD HD SZ 44MM-771660 11-104109-MLRY-HD POR FMRL 9X150MM-379420 139256-M2A-MAGNUM 42-50 TPR INSRT STD-507180 THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO CONCERNS OF METALLOSIS. DURING REVISION, A FAIR AMOUNT OF METAL-STAINED FIBROUS DEBRIS IN THE ANTERIOR ASPECT OF THE CAPSULE WAS ENCOUNTERED AS WELL AS MILD OXIDATION ON THE TRUNNION. THE FEMORAL HEAD AND NECK WERE REPLACED WITH A BIOLOX DELTA HIP SYSTEM WITHOUT COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2178157 | M2A-MAGNUM PF CUP 50ODX44ID | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 920660 | |
| 2204653 | M2A-MAGNUM PF CUP 50ODX44ID | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 920660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| H |