BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOLOX DELTA HIP

    MDR report key: 1943625 · Received December 14, 2010

    Report

    Report Number
    1644408-2010-00677
    Event Type
    Other
    Date Received
    December 14, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LZO
    PMA / PMN Number
    K082844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT COMPLAINED OF PAIN AT THE WOUND SITE SEVERAL WEEKS POST-OP. THE TESTS CAME BACK POSITIVE FOR AN INFECTION. THE DOCTOR BELIEVED THE INFECTION WARRANTED A TWO STAGE REVISION. STAGE ONE WAS, IMPLANT REMOVAL AND INSERTION OF CEMENT SPACER. THE ORIGINAL IMPLANTS WERE IN GOOD POSITION AND WELL FIXED AFTER 8+ WEEKS IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX DELTA HIP DELTA CERAMIC HEAD LZO ENCORE MEDICAL, L.P. A1000000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention