BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 52MM

    MDR report key: 1060371 · Received June 11, 2008

    Report

    Report Number
    2249697-2008-00163
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE INCIDENT SHALL BE PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE REPORTED EVENT. INFO IS NOT AVAILABLE AT THIS TIME. WHEN IT BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "CUP WAS EXTREMELY LOOSE ANS SEEMS TO BE ASCEPTIC LOOSENING. REP IS SENDING BACK CUP FOR EVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention