BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 52MM

    MDR report key: 2132584 · Received June 10, 2011

    Report

    Report Number
    9616680-2011-00381
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 22, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE, ALTHOUGH IT HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 623-00-36E, LOT # 35548601, DESCRIPTION: TRIDENT 0 X3 INSERT 36MM ID; CAT # 6191-0-001, LOT # JJR038, DESCRIPTION: SURGICAL SIMPLEX CEMENT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT HAD AN INFECTION AFTER THE THA. THE SURGEON REQUESTED EACH STERILIZATION CERTIFICATES ON THE PRODUCTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 35534701

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other