BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 60

    MDR report key: 2954187 · Received February 11, 2013

    Report

    Report Number
    1818910-2013-01953
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    August 15, 2012
    Report Date
    February 5, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 2010. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Description of Event or Problem · 1

    ASR REVISION; ASR RESURFACING - RIGHT HIP; REASON(S) FOR REVISION: PAIN; INCREASED METAL ION LEVELS; FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58219 ASR ACETABULAR IMPLANT 60 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 1159038

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention