BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC 52/46MM

    MDR report key: 2850268 · Received November 29, 2012

    Report

    Report Number
    3002806535-2012-00359
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. IMPLANT DATE - UNKNOWN. DEVICE EVALUATION IN PROCESS. UPON COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE RETURNED IMPLANTS WERE EVALUATED AND FOUND BURNISHING OF THE POROUS COATING WHICH IMPLIES THAT THERE WAS SOME LOOSENING OF THE SHELL, DESPITE THE SUBSTANTIAL BONE INGROWTH ON ITS POROUS COATED SURFACE. THE APPARENT SMALL WEAR STRIPE ON THE HEAD IMPLIES THAT THERE MAY HAVE BEEN A DEGREE OF RIM LOADING, WHICH COULD HAVE RESULTED FROM JOINT LAXITY OR A HIGH INCLINATION ANGLE OF THE CUP. WITHOUT RADIOGRAPHS HOWEVER, POSITION AND ALIGNMENT CANNOT BE ASSESSED, AND A MORE DEFINITE CONCLUSION AS TO THE CAUSE FOR REVISION CANNOT BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY HIP PROCEDURE ON AN UNKNOWN DATE. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PAIN AND FLUID COLLECTION AROUND HIP. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECAP SHELL COCR PC 52/46MM RECAP/MAGNUM SHELL KWA BIOMET UK LTD. N/A 1505663

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R