BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM

    MDR report key: 8103633 · Received November 26, 2018

    Report

    Report Number
    0001825034-2018-10722
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    October 18, 2017
    Report Date
    November 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: US157858, ITEM NAME: M2A-MAGNUM PF CUP 58ODX52ID, LOT #: 871440. ITEM NUMBER: 13-103206, ITEM NAME: TAPERLOC POR RED/LAT 12.5X145, LOT #: 972280. ITEM NUMBER: 139264, ITEM NAME: M2A-MAGNUM 52-60MM TPR INSRT-6, LOT #: 263510. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10721. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 9 YEARS POST-IMPLANTATION DUE TO "METALOSIS" AND EROSION OF THE PROXIMAL FEMUR. DURING REVISION SURGERY EXTENSIVE METALLOSIS IN SERUM, A "PSUEDOTUMOR", EROSION OF THE PROXIMAL FEMUR, AND A FLUID COLLECTION WAS NOTED. IT WAS ALSO NOTED THAT THE HIP WAS DIFFICULT TO DISLOCATE DURING REVISION SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942080 M2A-MAGNUM MOD HD SZ 52MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 541690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R