BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM

    MDR report key: 3022823 · Received March 21, 2013

    Report

    Report Number
    MW5029493
    Event Type
    Injury
    Date Received
    March 21, 2013
    Report Date
    March 20, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2009. I REC'D THE DEPUY TOTAL HIP SYSTEM PINNACLE 100 ACETABULAR CUP SZ MM50. PRIOR TO SURGERY, I HAD SEVERE PAIN WITH ANY RANGE OF MOTION. I HAD PAIN AGAIN IN THE GROIN AND I HAD DIFFICULTY WALKING LONG DISTANCES. AFTER SURGERY, THE PAIN WENT AWAY BUT THEN IN THE (B)(6) 2011, I HAD PAIN LOCATED TO THE GROIN AND IT RADIATED TO MY THIGH. THE PAIN INCREASED WHEN I WAS WALKING ANY DISTANCES OVER 10 MINS. I WAS HAVING PROGRESSIVE LOSS OF SUPPORT OF THE FEMORAL STEM WHICH LEAD TO TOTAL FAILURE OF THE JOINT. I HAD TO HAVE A REVISION OF MY LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2011 REQUIRING ADD'L HOSPITALIZATION. DATES OF USE: (B)(6) 2009 - (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: LEFT HIP OSTEOARTHROSIS. ON (B)(6) - (B)(6) 2011 - INPATIENT REHABILITATION. ON (B)(6) - (B)(6) 2011 - PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117922 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM HIP IMPLANT METAL INSERT KWA DEPUY ORTHOPAEDICS, INC. 1218-87-360 286673
    117923 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM HIP IMPLANT CUP KWA DEPUY ORTHOPAEDICS, INC. 1217-01-050 DD6JS1000
    117924 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM HIP IMPLANT CORAIL LZO DEPUY ORTHOPAEDICS, INC. 2706449
    117925 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM HIP IMPLANT FEMORAL HEAD KWA DEPUY ORTHOPAEDICS, INC. 1365-36-310 2836820
    118009 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM HIP IMPLANT HOLE ELIMINATOR JDI DEPUY ORTHOPAEDICS, INC. 1246-03-000 DD9K31000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S