BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM SYSTEM

    MDR report key: 6415391 · Received March 17, 2017

    Report

    Report Number
    0001825034-2017-01529
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    February 13, 2017
    Report Date
    March 13, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. ADDITIONALLY, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTOR WITH NO DEVIATIONS OR ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT ¿ M2A MAGNUM HEAD CATALOG#: 157448, LOT#: 164347. M-H PC CATALOG#: 11-104111, LOT#: 011240. M2A MAGNUM INSERTER CATALOG#: 139252, LOT#: 872810. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THAT PATIENT UNDERWENT A LEFT HIP REVISION EIGHT YEARS POST-IMPLANTATION DUE TO LOOSENING OF THE ACETABULAR CUP. DURING THE PROCEDURE, THE CUP WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195647 M2A MAGNUM SYSTEM PROSTHESIS, CUP KWA BIOMET ORTHOPEDICS N/A 452550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R