BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 44

    MDR report key: 3122030 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-05861
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    November 4, 2012
    Report Date
    May 13, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL ACETABULAR SYSTEM - RIGHT, REASON(S) FOR REVISION: ACETABULAR COMPONENT LOOSENING, PAIN.

    Description of Event or Problem · 1

    UPDATED TO LEGAL, CORRECTED PATIENT NAME AND ADDED GENDER AND DATE OF BIRTH. UPDATED MANUFACTURE AND EXPIRY DATES FOR CUP AND HEAD. UPDATED FAILURE CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224276 ASR ACETABULAR IMPLANT 44 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 1839870

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention