BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL SYS 8/12.0 LRG ST

    MDR report key: 4192526 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30414
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK060581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. THE DEVICE HISTORY RECORDS FOR THE REPORTED FEMORAL STEM WAS CLOSELY EXAMINED WITH NO MANUFACTURING DEVIATIONS OR ANOMALIES FOUND. IT WAS ALSO DETERMINED THAT THERE ARE NO OTHER PRODUCT COMPLAINTS FOR THE COMPONENT PRODUCTION LOT AS THE COMPLAINT PRODUCT. THIS WOULD STRONGLY SUGGEST THERE IS NO DEFECT OR ERRORS IN THE MATERIALS OR MANUFACTURING PROCESSES FOR THESE IMPLANT LOTS. ADDITIONALLY, RESEARCH USING THE AS400 SYSTEM INDICATES THAT SEVERAL PIECES FROM THE REPORTED LOT HAVE BEEN DELIVERED, AND, AS NO ADDITIONAL REPORTS HAVE BEEN RECEIVED, CAN BE REASONABLY ASSUMED IMPLANTED WITHOUT ISSUE. MEDICAL RECORDS AND X-RAYS WERE REVIEWED. THE PATIENT IS CONSIDERED OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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).

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO THE STEM BREAKING. IT IS UNKNOWN WHAT MAY HAVE CAUSED THE STEM TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672807 SOL SYS 8/12.0 LRG ST HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS INC US DN5HT1000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention ALTRX +4 10D 36IDX54OD| ARTICULEZE M HEAD 36MM +5| PINN CAN BONE SCREW 6.5MMX30MM| PINN SECTOR W/GRIPTION 54MM