BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM

    MDR report key: 6471657 · Received April 7, 2017

    Report

    Report Number
    0001825034-2017-02394
    Event Type
    Injury
    Date Received
    April 7, 2017
    Date of Event
    March 10, 2017
    Report Date
    January 17, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS - M2A 38 MM ONE PIECE CUP SZ 52 MM/ PN 15-105052/ LN 990580, TAPERLOC POR RED/LAT 12.5X145/ PN 13-103206/ LN 749920. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02392, 0001825034-2017-02393.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 THAT THE PATIENT'S HIP WAS REVISED APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO METALLOSIS AND INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH SPACERS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256029 TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 076800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R