BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM ST,36+6L NK,11X16X150

    MDR report key: 3253863 · Received July 30, 2013

    Report

    Report Number
    1818910-2013-22449
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    9616671 DEPUY IRELAND
    Product Code
    LPH
    PMA / PMN Number
    PK954935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES RETURNED TWO OTHER REPORTS AGAINST THE 1960650 LOT CODE WITH UNDETERMINED CONCLUSIONS, WHILE NO OTHER REPORTS WERE FOUND AGAINST THE 1905284 AND 1944324 LOT CODES. A REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF PROVIDED PATIENT X-RAYS FINDS THE FEMORAL STEM APPEARS TO BE IN VARUS AT TIME THE IMAGE WAS TAKEN. THE STEM APPEARS TO BE DISTALLY IMPINGING ON THE LATERAL CORTICAL WALL; THERE IS ALSO A CORTICAL BONE PROJECTION (POSSIBLY FROM BONE REMODELING) DISTAL TO THE STEM LEADING UP TO THE CENTER OF THE DISTAL TIP. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REASON FOR REVISION: LOOSE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355003 SROM STM ST,36+6L NK,11X16X150 FEMORAL HIP STEM LPH 9616671 DEPUY IRELAND 1960650

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention