BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 ACETABULAR CUP

    MDR report key: 6724760 · Received July 19, 2017

    Report

    Report Number
    0001825034-2017-05034
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    September 16, 2015
    Report Date
    July 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS - ACTIVE ARTICULATION BEARING P/N EP-200144 L/N 603340, BIOLOX DELTA CERAMIC HEAD P/N 650-1055 L/N 501300, BIOLOX DELTA CERAMIC TAPER SLEEVE P/N 650-1068 L/N 281030. DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED; HOWEVER, THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THESE TYPES OF EVENTS CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY 1 YEAR POST-IMPLANTATION DUE TO ISSUES FROM THE PRIOR REVISION SURGERY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT NOTED REVISION DUE TO RECURRENT DISLOCATIONS WITH INSTABILITY DUE IN PART TO METAL ON METAL ADVERSE TISSUE EFFECTS CAUSING LOSS OF GLUTEUS MEDIUS/ABDUCTOR MUSCLE. THE CUP, HIP BEARING, AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507047 M2A-38 ACETABULAR CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 969860

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R SEE H10 NARRATIVE