BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SUMMIT TAPERED HIP STEM WITH POROCOAT

    MDR report key: 2994277 · Received March 1, 2013

    Report

    Report Number
    MW5029236
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    LWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECALLED DEPUY ASR RIGHT TOTAL HIP HARDWARE REMOVED AND REPLACED DURING HIP REVISION SURGERY. DEPUY SUMMIT TAPERED HIP STEM WITH POROCOAT, SIZE 5 145MM LGT, HI OFFSET, 12/14 TAPER, 1570-11-110, LOT NUMBER: A78G71000. DEPUY ASR TAPER SLEEVE ADAPTOR 12/14 TAPER, 9998-00-315, LOT NUMBER: 2092456. DATES OF USE: 6 YEARS; (B)(6) 2007- (B)(6) 2013. DIAGNOSIS: RIGHT TOTAL HIP REPLACEMENT. EVENT ABATED AFTER USE STOPPED OR REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89909 DEPUY SUMMIT TAPERED HIP STEM WITH POROCOAT TOTAL RIGHT HIP HARDWARE - TOTAL HIP REPLACEMENT LWJ DEPUY ORTHOPAEDICS 1570-11-110 A78G71000
    90125 DEPUY ASR ACETABULAR CUP TOTAL RIGHT HIP HARDWARE KWA DEPUY INTERNATIONAL 9998-00-758 2123922
    90126 UNI FEMORAL IMPLANT TOTAL RIGHT HIP HARDWARE KWY DEPUY INTERNATIONAL 9998-90 2174110
    90127 DEPUY ASR TAPER SLEEVE ADAPTER TOTAL RIGHT HIP HARDWARE - TOTAL HIP REPLACEMENT KWA DEPUY ORTHOPAEDICS 998-00-315 2092456

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention