BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP FEM HD COCR CEMENTED DIA50MM

    MDR report key: 4173414 · Received October 15, 2014

    Report

    Report Number
    3002806535-2014-00232
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 18, 2014
    Report Date
    November 7, 2014
    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
    US
    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE HEAD REVEALED EVIDENCE OF SCRATCHING AND WEAR. EXAMINATION OF RADIOGRAPHIC IMAGES RECEIVED SHOW POSSIBLE RADIOLUCENCIES ADJACENT TO THE FRACTURE. IT IS POSSIBLE THAT THIS OCCURRED AS A RESULT OF THE DISPLACEMENT OF THE FEMORAL STEM AFTER FRACTURE OR AS A RESULT OF BONE RESORPTION IN THIS AREA PRIOR TO FRACTURE. SINCE THE FRACTURE OCCURRED 6 YEARS AFTER THE INITIAL IMPLANTATION, IT WOULD SUGGEST THAT EITHER A TRAUMATIC EVENT OR PATIENT DEGENERATIVE BONE CONDITION MAY HAVE RESULTED IN THE FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT THE PATIENT UNDERWENT A HIP REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2014 DUE TO A FEMUR NECK FRACTURE. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653808 RECAP FEM HD COCR CEMENTED DIA50MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1128000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R