BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 13579223 · Received February 22, 2022

    Report

    Report Number
    0001825034-2022-00347
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    September 19, 2018
    Report Date
    April 12, 2022
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 192411 ECHO POR FMRL STEM 307380; 139258 M2A-MAGNUM 42-50M TPR 496010; 157450 M2A-MAGNUM MOD HEAD 012580. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. 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: 0001825034-2022-00348.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, H2, H3, H6. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND EXAMINATION OF PRODUCT SAMPLE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS IDENTIFIED THE FOLLOWING: POSTERIOR LATERAL APPROACH, METALLOSIS WAS FOUND. DEBRIDEMENT OF METALLOSIS WAS COMPLETED. TRUNNION AND ACETABULUM NO WEAR AND REMAINED IMPLANTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. THE PATIENT WAS REVISED DUE TO METALLOSIS NINE YEARS POST IMPLANTATION. DURING THE REVISION METALLOSIS WAS DEBRIDED, TRUNNION AND ACETABULUM HAD NO NOTICEABLE WEAR WAS NOTED AND REMAINED IMPLANTED. THE HEAD WAS EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1005839 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 664000

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Hospitalization| R SEE H10