BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 55

    MDR report key: 2873802 · Received December 14, 2012

    Report

    Report Number
    1818910-2012-25849
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 27, 2012
    Report Date
    July 17, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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).

    Description of Event or Problem · 1

    17 JULY 2015 - UPDATE - RCVD (B)(6) UPDATE - AMEND TO LEGAL.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL ACETABULAR SYSTEM - RIGHT; REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 55 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 1852476

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention