BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE ACETABULAR CUP SYSTEM, SZ 52MM

    MDR report key: 3020663 · Received March 18, 2013

    Report

    Report Number
    MW5029433
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    September 8, 2009
    Report Date
    March 18, 2013
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PARTIAL DISLOCATION. FLUID IN OR AROUND THE JOINT. FLUID COLLECTION IN THE MUSCLE AROUND THE JOINT AND LOOSENING OF THE IMPLANT. CONTINUED PAIN. CONTINUED PROBLEMS WALKING. CONTINUED PAIN SITTING. LEFT HIP REPLACEMENT. INDICATIONS: LEFT HIP DYSPLASIA, LEFT HIP OSTEOARTHRITIS. CONSULTS WITH OTHER DOCTORS (B)(6) 2009 TO (B)(6) 2012 FOR PAIN AND WALKING PROBLEMS. PAIN MEDICATION FROM 2009 TO PRESENT. PHYSICAL THERAPY IN (B)(6) 2011 AND (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112072 PINNACLE ACETABULAR CUP SYSTEM, SZ 52MM PINNACLE HIP IMPLANT WITH MOM LINER, CUP KWA JOHNSON & JOHNSON DX1CX1000
    112073 PINNACLE ACETABULAR CUP SYSTEM, METAL INSERT PINNACLE HIP IMPLANT WITH MOM LINER, INSERT LPH JOHNSON & JOHNSON 2941825
    112074 PINNACLE ACETABULAR CUP SYSTEM, BONE SCREW 6.5MM, MM LGT 30 PINNACLE HIP IMPLANT WITH MOM LINER, BONE SCREW KWA JOHNSON & JOHNSON DGA9400
    112075 PINNACLE ACETABULAR CUP SYSTEM, APEX HOLE ELIMINATOR PS PINNACLE HIP IMPLANT WITH MOM LINER, HOLE ELIMINATOR LPH JOHNSON & JOHNSON D21JM1000
    112076 PINNACLE ACETABULAR CUP SYSTEM, BONE SCREW 6.5MM, MM LGT 35 PINNACLE HIP IMPLANT WITH MOM LINER, BONE SCREW LPH JOHNSON & JOHNSON C97KD4000
    112077 PINNACLE ACETABULAR CUP SYSTEM, FEMORAL STEM STANDARD PINNACLE HIP IMPLANT WITH MOM LINER, FEMORAL STEM LPH JOHNSON & JOHNSON 2443092
    112078 PINNACLE ACETABULAR CUP SYSTEM, ZTT PROXIMAL SLEEVE 14 B SML PINNACLE HIP IMPLANT WITH MOM LINER, SLEEVE LPH JOHNSON & JOHNSON 1237696
    112079 PINNACLE ACETABULAR CUP SYSTEM, METAL ON METAL FEMORAL HEAD 36MM +6 11/13 TAPER PINNACLE HIP IMPLANT WITH MOM LINER, FEMORAL HEAD LPH JOHNSON & JOHNSON 2844161

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR