BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED ACETABULAR INSERTS

    MDR report key: 2127074 · Received June 6, 2011

    Report

    Report Number
    2249697-2011-00817
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 14, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNK CEMENT WAS USE IN THIS CASE AND REQUESTED FOR CEMENT INFO BUT NOT MADE AVAILABLE. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD CEMENTED CONSTRAINED LINER WITH 22MM +0 C-TAPER HEAD CEMENTED EON OR HFX STEM. STEM WAS LEFT IN THE PT. THE DOCTOR SAID THE FAILURE OF THIS CONSTRUCT WAS THE CEMENT NOT THE CONSTRAINED LINER. DEVICE IS NOT BEING RETURNED. THE DOCTOR KEEPS ALL EXPLANTS THAT HE REMOVES. REPLACED HEAD WITH 06-3600 LOT# MJPDPA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTRAINED ACETABULAR INSERTS IMPLANT KWZ STRYKER ORTHOPAEDICS MAHWAH NA 24526761

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R