BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T UNIV 2-HOLE SHL

    MDR report key: 6808844 · Received August 21, 2017

    Report

    Report Number
    0001825034-2017-06565
    Event Type
    Injury
    Date Received
    August 21, 2017
    Date of Event
    April 7, 2008
    Report Date
    August 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BASED ON THE INITIAL INFORMATION AND THE INFORMATION FROM INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: M2A HI CARBON TAPER LINER P/N 15-105011 L/N 234270; M2A HI CARBON MODULAR HEAD P/N 11-163677 L/N 050590; TI LOW PROFILE SCREW P/N 103536 L/N 263780; TI LOW PROFILE SCREW P/N 103533 L/N 752490; TAPERLOC FEMORAL P/N 11-103206 L/N 992660. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-06004, 0001825034-2017-06005, 0001825034-2017-06565. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. IT WAS NOTED THAT THE PATIENTS' HIP HAD DISLOCATED ANTERIORLY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISLOCATION ON THE SAME DAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589007 M2A-T UNIV 2-HOLE SHL PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 994630

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R