BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE ACETABULAR CUP SYSTEM 52MM

    MDR report key: 2883924 · Received December 17, 2012

    Report

    Report Number
    MW5028247
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 14, 2005
    Report Date
    November 29, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(6) HAD A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2005. SHE RECEIVED THE PINNACLE SECTOR II ACETABULAR CUP SIZE 52MM, PERMANENT 36MM INTERNAL DIAMETER METAL LINER, AND A SUMMIT SIZE 4 STANDARD OFFSET POROCOAT STEM. PRIOR TO SURGERY, (B)(6) HAD INCREASING PAIN AND DISABILITY IN THE RIGHT HIP DUE TO DEGENERATIVE ARTHRITIS OF THE RIGHT HIP. ON (B)(6) 2006, (B)(6) HAD SOME PAIN WITH RANGE OF MOTION. ON (B)(6) 2009, (B)(6) REPORTED HAVING SOME CLICKING ON THE RIGHT SIDE WHEN WALKING AND SOME PAIN. IN (B)(6) 2011, (B)(6) WAS FOUND TO HAVE ELEVATED ION LEVELS. AS OF (B)(6) 2011, LEVELS ARE STILL ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE ACETABULAR CUP SYSTEM 52MM METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS INC ZN7CV1000
    2 36MM INTERNAL METAL LINER METAL LINER KWA DEPUY ORTHOPAEDICS INC
    3 SUMMIT 4 PROCOAT STEM STEM LWJ DEPUY ORTHOPAEDICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R| S