BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM SYSTEM CUP

    MDR report key: 6810389 · Received August 22, 2017

    Report

    Report Number
    0001825034-2017-06157
    Event Type
    Injury
    Date Received
    August 22, 2017
    Date of Event
    July 25, 2017
    Report Date
    September 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): (B)(6) 2017. ITEM #14-103207 TAPERLOC MICROP FMRL 13.5MM, LOT #900660.  REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    (B)(4). CONCOMITANT PRODUCT: 139254 M2A-MAGNUM 42-50MM TPR INSRT-3, LOT # 149410. 157450 M2A-MAGNUM MOD HD SZ 50MM, LOT # 721190. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS REPORTED. 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 THE PATIENT WAS REVISED FOR PAIN SECONDARY TO LOOSENING OF THE ACETABULAR CUP. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592311 M2A MAGNUM SYSTEM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 031030

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R