BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 8063828 · Received November 13, 2018

    Report

    Report Number
    0001825034-2018-10590
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    January 4, 2018
    Report Date
    November 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES AND X-RAYS. X-RAYS TAKEN BEFORE THE REVISION NOTES MILD ECCENTRIC FEMORAL HEAD POSITION AND CORTICAL DISCONTINUITY OF THE LATERAL ASPECT OF THE GREATER TROCHANTER CONSISTENT WITH A FRACTURE OF UNKNOWN AGE. OPERATIVE NOTES FROM THE REVISION SURGERY NOTE THE PATIENT WAS EXPERIENCING PAIN. THE FEMORAL HEAD WAS DISASSOCIATED FROM THE STEM WITH NO CORROSION NOTED ON THE TRUNNION. THE CUP WAS REMOVED AND REPLACED WITH A LARGER SIZE ALONG WITH TWO SCREWS AND LINER. A NEW HEAD COMPONENT WAS ALSO IMPLANTED TO EQUILIBRATE LIMB LENGTH AND STABILITY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). US157854 ¿ M2A MAGNUM CUP ¿ 091420. 11-103205 ¿ TAPERLOC FEMORAL STEM ¿ 758290. 139256 ¿ M2A MAGNUM TAPER INSERT ¿ 446680. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION HAS THE PRODUCT LOCATION IS UNKNOWN. 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 - 2018 - 10587; 0001825034 - 2018 - 10592. 0001825034 - 2018 - 10593.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO PAIN, METALLOSIS, BONE FRACTURE AND DISASSOCIATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906678 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 436640

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R . | .