BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 6623239 · Received June 8, 2017

    Report

    Report Number
    0001825034-2017-03554
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    October 3, 2016
    Report Date
    January 27, 2018
    Manufacturer
    .
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - M2A-MAGNUM PF CUP 52ODX46ID/ PN US157852/ LN 147820, PROGRESSIVE POR FMRL 9X125 LT/ PN 166315/ LN 843580, M2A-MAGNUM 42-50MM TPR INSRT-3/ PN 139254/ LN 244050. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. THE CORRECTIONS CONTAINED WITHIN THIS REPORT HAVE NO EFFECT ON PREVIOUS INVESTIGATION CONCLUSION. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THESE TYPE OF EVENTS CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE COULD NOT 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY SIX YEARS POST IMPLANTATION DUE TO PATIENT ALLEGATIONS OF FAILED LEFT TOTAL HIP ARTHROPLASTY. STEM AND CUP WERE NOTED TO BE STABLE. DUAL MOBILITY HEAD AND LINER WERE IMPLANTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY SIX YEARS POST IMPLANTATION DUE TO METALLOSIS AND ELEVATED METAL ION LEVELS. REVISION OPERATIVE REPORT NOTED METALLOSIS IN THE JOINT CAVITY AND THE FEMORAL STEM AND ACETABULAR CUP WERE NOT REVISED, AS THEY WERE STABLE. THE FEMORAL HEAD WAS REMOVED AND REPLACED AND A DUAL MOBILITY BEARING WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406191 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA . N/A 231820

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R