BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT

    MDR report key: 1132059 · Received August 21, 2008

    Report

    Report Number
    2249697-2008-00240
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 29, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN. IF DEVICE BECOMES AVAILABLE WITH ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE SALES REP THAT, " THE CONSTRAINED CUP DISLOCATED AND THE PT UNDERWENT A REVISION PROCEDURE FOR ITS REMOVAL AND REPLACEMENT. IT IS FURTHER REPORTED THAT THE LARGER OF THE TWO HEADS HAD 'POPPED' OUT OF ITS CONSTRAINTS AND THE METAL RETAINING RING FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention