BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL GEO.M/S SCREWLESS CUP 56MM

    MDR report key: 1993493 · Received February 8, 2011

    Report

    Report Number
    2249697-2011-00138
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 14, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDJ
    PMA / PMN Number
    K925883
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR# 2249697-2011-00137.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT HEARD A POP ON THE EVENING OF (B)(6) 2010 AND WAS TAKEN TO THE HOSP. TESTS REVEALED THAT THE CERAMIC HEAD BALL WAS FRACTURED." THE SALES REP REPORTED THAT THE REVISION SURGEON SAID, THE ACETABULAR SHELL WAS TOO VERTICLE. THERE WAS VERY POOR POSITIONING OF THE CUP. THERE WAS INCREASED WEAR ON SUPERIOR LIP OF CUP. THE POOR POSITIONING OF THE CUP CAUSED THE FRACTURE. SEVERE WEAR SHOWS THAT THIS HAS BEEN EFFECTING THE IMPLANT FOR A LONG TIME AND THAT THE PT SHOULD HAVE NOTICED SYMPTOMS AND REPORTED TO A PHYSICIAN MUCH SOONER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL GEO.M/S SCREWLESS CUP 56MM IMPLANT JDJ STRYKER ORTHOPAEDICS MAHWAH NA RL3053

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R