BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM +5MM FEMORAL HEAD

    MDR report key: 2981243 · Received February 27, 2013

    Report

    Report Number
    0002249697-2013-00795
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING DISLOCATION INVOLVING A METAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED AS THE PATIENT KEPT IT. DEVICE HISTORY REVIEW INDICATED ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, OPERATIVE REPORTS, XRAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF AN OLD STRYKER HIP. SURGEON REMOVED CUP AND LINER AND POPPED OFF PSA HEAD. PATIENT HAD DISLOCATION AND BIOMET THAT WAS PLACED VERTICALLY AND KEPT DISLOCATING. CLARIFICATION RECEIVED FROM THE SALES REP ON (B)(6) 2013, INDICATED THAT THE ONLY STRYKER DEVICE THAT WAS REVISED ON (B)(6) 2013, WAS THE REPORTED HEAD. HE STATES THAT THE HEAD WAS IMPLANTED IN TEXAS APPROXIMATELY 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF AN OLD STRYKER HIP. SURGEON REMOVED CUP AND LINER AND POPPED OFF PSA HEAD. PATIENT HAD DISLOCATION AND BIOMET THAT WAS PLACED VERTICALLY AND KEPT DISLOCATING. CLARIFICATION RECEIVED FROM THE SALES REP ON (B)(4) 2013, INDICATED THAT THE ONLY STRYKER DEVICE THAT WAS REVISED ON (B)(6) 2013, WAS THE REPORTED HEAD. HE STATES THAT THE HEAD WAS IMPLANTED IN TEXAS APPROXIMATELY 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83350 32MM +5MM FEMORAL HEAD IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH 38086901

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O| R