BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 50ODX44ID

    MDR report key: 8096751 · Received November 21, 2018

    Report

    Report Number
    0001822565-2018-06557
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    August 8, 2018
    Report Date
    November 21, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A MAGNUM CUP, CATALOG #: US157850, LOT #: 011000, M2A MAGNUM HEAD, CATALOG #: 157444, LOT #: 368540, ECHO FEMORAL, CATALOG #: 192412, LOT #: 262570. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OPERATIVE NOTES RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED WITH NO DEVIATIONS IDENTIFIED. A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. MULTIPLE MDR REPORTS WERE FILED, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-06557, 0001825034-2018-08306, 0001825034-2018-10832. 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO PAIN AND ELEVATED ION LEVELS. FURTHER, THERE WAS MALPOSITIONING AND BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934675 M2A-MAGNUM PF CUP 50ODX44ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 011000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R