BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/+5

    MDR report key: 1915062 · Received November 30, 2010

    Report

    Report Number
    2249697-2010-01639
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. 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 CODE OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 623-00-36E, LOT# RIPMJE, DESCRIPTION: TRIDENT 0 X3 INSERT 36MM ID. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S CRACKING/SQUEAKING NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHEN THE PATIENT WALKED THE HIP WOULD MAKE A CRACKING/SQUEAKING NOISE. DURING THE REVISION SURGERY THE HEAD WAS REPLACED WITH A METAL HEAD AND NEW LINER. DURING SURGERY PHYSICIAN COULD NOT TRULY UNDERSTAND WHAT WAS CAUSING THE PROBLEM. HE FELT A LINER AND HEAD EXCHANGE WOULD SOLVE THE PROBLEM. XRAYS UNAVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V40 COCR LFIT HEAD 36MM/+5 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA NXNMEE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R