BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 54MM

    MDR report key: 1942455 · Received December 22, 2010

    Report

    Report Number
    2249697-2010-01854
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    February 27, 2007
    Report Date
    December 1, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 2030-6525-1, LOT # UNK, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 25MM. CAT # 623-00-36F, LOT # MP9MDA, DESCRIPTION: TRIDENT 0X3 INSERT 36MM ID. CAT # 6051-0525S, LOT # 35060501, DESCRIPTION: SECUR-FIT MAX. CAT # 06-3605, LOT # 89AMTA, DESCRIPTION: C-TAPER COCR LFIT HEAD 36MM/+5. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PT HAD BILATERAL HIP REPLACEMENTS. THE CATALOG NUMBERS LISTED ARE IMPLANTED IN THE PT RIGHT HIP. SHE HAS BEEN EXPERIENCING PAIN, A POPPING NOISE AND SWELLING IN BOTH OF THE HIPS. ON THE RIGHT SIDE, SHE FEELS A TINGLING SENSATION AND IT FEELS HEAVY. PT STATED IT WAS OKAY FOR STRYKER TO CONTACT HER SURGEONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA CLUSTER 54MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 606MLA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R