BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY HIP REPLACEMENT

    MDR report key: 2100930 · Received May 19, 2011

    Report

    Report Number
    MW5020669
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    November 1, 2009
    Report Date
    May 19, 2011
    Manufacturer
    DEPUY
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED LEFT LEG PAIN AFTER HIP REPLACEMENT SURGERY IN (B)(6) 2009. PT HAD 3 SPONTANEOUS DISLOCATIONS BETWEEN (B)(6) 2009 AND (B)(6) 2010. THIS RESULTED IN AMBULATION DIFFICULTIES AND AN EXTENDED PERIOD OF TIME OFF WORK. PT WAS REVISED (B)(6) 2011 WITH ANOTHER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY HIP REPLACEMENT PINNACLE ACETABULAR CUP 100 LPH DEPUY D232DJ1000
    2 DEPUY HIP REPLACEMENT PINNACLE METAL INSERT LPH DEPUY 2923414
    3 DEPUY HIP REPLACEMENT FEMORAL HEAD ARTICUL-EZE M LPH DEPUY 3000251
    4 DEPUY HIP REPLACEMENT APEX HOLE ELLIMINATOR - PS LPH DEPUY DSFNN1
    5 DEPUY HIP REPLACEMENT SUMMIT FEMORAL STEM 12-14 TAPERED LPH DEPUY D3VBL1

    Patients

    Seq Age Sex Outcome Treatment
    1