BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 54

    MDR report key: 3071158 · Received April 22, 2013

    Report

    Report Number
    1818910-2013-04962
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 5, 2013
    Report Date
    September 4, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. 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. REF. (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

    UPDATE 8 SEPTEMBER 2015: UPDATED AS LEGAL WITH (B)(4). ADDED NAME OF SURGEON AND HOSPITAL FOR PRIMARY SURGERY. ADDED MANUFACTURE AND EXPIRY DATES FOR CUP AND HEAD. TAKEN FROM ASR LEGAL CLAIM 7 SEPTEMBER 2015.

    Description of Event or Problem · 1

    ASR REVISION RIGHT, ASR XL; REASON(S) FOR REVISION: PAIN,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172708 ASR ACETABULAR IMPLANT 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 2303684

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORAIL2 STD SIZE 10.| DEPUY ASR XL FEM IMP SIZE 47.| TAPER SLEEVE ADAPTER 12/14 +2.