BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM RECAP CUP 62ODX56ID

    MDR report key: 14879069 · Received June 30, 2022

    Report

    Report Number
    0001825034-2022-01536
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    October 6, 2021
    Report Date
    August 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 139266, LOT# 687000, M2A-MAGNUM 52-60MM TPR INSRT. CAT# 157456, LOT# 339460, M2A-MAGNUM MOD HD. CAT# 192017, LOT# 220590, ECHO POR FMRL. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01537, 0001825034-2022-01538.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. PARTIAL TEAR OF GLUTEUS MEDIUS, HO, COBALT LEVEL 7.8, CHROMIUM 5.7, SYNOVITIS AND FLUID WITH DISCOLORATION, STEM WELL FIXED NO INTRA-OP COMPLICATIONS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 11 YEARS POST IMPLANTATION DUE TO METALLOSIS AND PROGRESSIVE PAIN. DURING THE REVISION, A CHRONIC PARTIAL TEAR OF THE GLUTEUS MEDIUS WAS FOUND WITH A SMALL HETEROTOPIC BONE FRAGMENT ATTACHED, FROM OSSIFICATION. A SYNOVECTOMY WAS PERFORMED AROUND THE HIP WITH SYNOVITIS NOTED AROUND THE GREATER TROCHANTER. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376264 M2A-MAGNUM RECAP CUP 62ODX56ID PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 711790

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE.