BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY HPS

    MDR report key: 1924009 · Received December 9, 2010

    Report

    Report Number
    MW5018541
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 27, 2010
    Report Date
    December 2, 2010
    Manufacturer
    DEPUY ORTHOPEDICS
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EXPLANTATION OF THE DEPUY HPS. STEM AND ASR CUP AND HEAD. HERE ARE ALL THE IMPLANT'S SERIAL NUMBERS AND LOT NUMBERS THAT WERE IMPLANTED ON (B)(6) 2006: ACETABULAR CUP, (B)(4), LOT# 1989378. HIP W/ STEM, (B)(4), LOT# Z4KHM1000. SLEEVE, (B)(4), LOT# 2142134. FEMORAL, (B)(4), LOT# 2163404.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY HPS RIGHT HIP PROSTHESIS, SLEEVE KWA DEPUY ORTHOPEDICS * 2142134
    2 DEPUY HPS ACETABULAR CUP KWA DEPUY ORTHOPEDICS 1989378
    3 DEPUY HPS HIP W STEM KXA DEPUY ORTHOPEDICS Z4KHM1000
    4 DEPUY HPS FEMORAL KXA DEPUY ORTHOPEDICS 2163404

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention