BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 46

    MDR report key: 3024052 · Received March 27, 2013

    Report

    Report Number
    1818910-2013-04510
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    August 7, 2011
    Report Date
    March 24, 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
    AS
    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. (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.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    (B)(4). ASR REVISION RECOMMENDED. ASR XL ACETABULAR SYSTEM (RIGHT). UPDATE: ADDED HOSPITAL, REASON FOR REVISION AND DATE OF REVISION. RECEIVED: MARCH 19TH 2013. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE 24 MAR 2015. ADDED TAPER SLEEVE AND UNK STEM ((B)(6) 2015). CONFIRMATION RECEIVED 02 APR 2015 NO STEM DETAILS AVAILABLE ((B)(6) 2015).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126374 DEPUY ASR XL FEM IMP SIZE 46 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2295487

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention