BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 53

    MDR report key: 3032610 · Received April 3, 2013

    Report

    Report Number
    1818910-2013-04533
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    January 17, 2012
    Report Date
    March 7, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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: COMPONENT LOOSENING.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR REVISION TO TAKE PLACE ON (B)(6) 2012, ASR XL ACETABULAR SYSTEM - RIGHT, REASON(S) FOR REVISION: UNKNOWN. UPDATE: ADDED REVISION REASON AND SURGEON FORENAME. RECEIVED: MARCH 26TH 2013. REASON(S) FOR REVISION: COMPONENT LOOSENING - ACETABULAR COMPONENT. ENQUIRING INTO WHICH COMPONENT BECAME LOOSE. UPDATE RECEIVED 7TH MARCH 2014. PRODUCT CODE AND LOT NUMBERS AMENDED FOR CUP AND HEAD. TAPER SLEEVE ADDED. ADDITIONAL HOSPITAL ADDED AND HOSPITAL AMENDED. KID ADDED AND STATUS CHANGED TO "LEGAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135803 DEPUY ASR XL FEM IMP SIZE 53 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2431238

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention