BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 PPS SO 11.0

    MDR report key: 3092050 · Received May 3, 2013

    Report

    Report Number
    3002806535-2013-00068
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP PROCEDURE ON (B)(6) 2013. AFTER IMPLANTATION, THE SURGEON DECIDED TO REMOVE THE IMPLANTS DUE TO STABILITY ISSUES. PROCEDURE WAS COMPLETED WITH A HIGH OFFSET FEMORAL. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194210 TPRLC 133 TYPE1 PPS SO 11.0 PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 2624173

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R