BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 16D-LRG

    MDR report key: 5567636 · Received April 11, 2016

    Report

    Report Number
    1818910-2016-17099
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 7, 2016
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    CLINICAL REPORT STATES THAT PATIENT EXPERIENCED AN INTRAOPERATIVE FEMORAL BONE FRACTURE. NO DEVICES WERE RETURNED FOR REVIEW. ONE OTHER REPORT FOUND AGAINST THE 8230706 LOT CODE. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO OTHER REPORTS FOUND AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATION. MEDICAL RECORDS AND X-RAYS WERE REVIEWED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT PATIENT EXPERIENCED AN INTRAOPERATIVE FEMORAL BONE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223711 S-ROM*SLEEVE PRX ZTT, 16D-LRG HIP FEMORAL STEM/SLEEVE LPH DEPUY IRELAND ¿ REG. # 9616671 8150325

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR