BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA ACETABULAR SHELL / OD 48MM

    MDR report key: 2233994 · Received August 31, 2011

    Report

    Report Number
    2249697-2011-01299
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    July 13, 2010
    Report Date
    August 15, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 623-10-32D, LOT # W86ML, DESCRIPTION: TRIDENT 10 X3 INSERT 32MM ID. CAT # UNK, LOT # UNK, DESCRIPTION: 127 SECURE-FIT MAX / SIZE 6. CAT # UNK, LOT # UNK, DESCRIPTION: C-TAPER 32MM FEMORAL HEAD / +0MM NECK LENGTH. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PATIENT HAS PAIN THAT STARTS ALONG THE GROIN AND SHOOTS DOWN TO THE KNEE. EVER SINCE HER SURGERY SHE HASN'T BEEN ABLE TO WALK OR BEND. SHE HAS FOLLOWED UP WITH HER SURGEON AND X-RAY HAVE BEEN TAKEN. SHE STATED THAT THE SURGEON TOLD HER THAT EVERYTHING LOOKS FINE FROM THE X-RAYS BUT SHE IS STILL HAVING THE SAME PROBLEMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA ACETABULAR SHELL / OD 48MM IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R