BEUDAMED
    FDA Adverse Event Summary report: N

    DEPUY PINNACLE 56 MM OUTER DIAMETER SECTOR LINER

    MDR report key: 2861330 · Received December 2, 2012

    Report

    Report Number
    MW5027942
    Date Received
    December 2, 2012
    Date of Event
    October 25, 2012
    Report Date
    December 2, 2012
    Manufacturer
    DEPUY
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PINNACLE HIP REPLACEMENT COMPONENTS FAILED 56MM OUTER DIAMETER PINNACLE SECTOR LINER 40 MM INNER DIAMETER METAL LINER 14 KARI COLLARED KLA STEM +5 40 MM OUTER DIAMETER HEAD. IMPLANT MOVED CAUSING SEVERE PAIN AND MOBILITY PROBLEMS 4 YEARS AND 3 MONTHS AFTER IMPLANTED, REVISION SURGERY TO REMOVED SCHEDULED FOR (B)(4) 2012, AT LEAST TEMPORARY DISABILITY TOTAL EFFECT CURRENTLY NOT KNOWN BECAUSE SURGERY IS NEXT THURSDAY. IMPLANT MOVED AND NOT ONLY EFFECTING HIP, BUT KNEE BECAUSE IMPLANT MOVED LATERALLY CAUSING KNEE TO TWIST DURING EVERY STEP. DATES OF USE: (B)(4) 2008 - (B)(4) 2012. DIAGNOSIS OR REASON FOR USE: HIP ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE 56 MM OUTER DIAMETER SECTOR LINER HIP REPLACEMENT IMPLANT KWA DEPUY 56 MM OUTER *
    2 40 MM INNER DIAMETER METAL LINER HIP REPLACEMENT IMPLANT KWA DEPUY
    3 14 KARI COLLARED KLA STEM + 5 HIP REPLACEMENT IMPLANT KWY DEPUY
    4 40 MM OUTER DIAMETER HEAD HIP REPLACEMENT IMPLANT KWY DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O| R| S