BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 45

    MDR report key: 2973917 · Received February 22, 2013

    Report

    Report Number
    1818910-2013-02611
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    February 7, 2013
    Report Date
    August 7, 2013
    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

    UPDATE RECEIVED: (B)(4) 2013 FROM QUERY - AMENDED SIDE HIP: **LEFT, AMENDED IMPLANT DATE: (B)(6) 2009, AMENDED REVISION DATE: REMOVED REVISION DATE AS YET TO BE REVISED, PLEASE SEE ATTACHED DOCUMENT. PLEASE NOTE ***REVISION REASON IS INVALID AS IT PREVIOUSLY REFERED TO THE RIGHT SIDE HIP. 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

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    UPDATE RECEIVED: (B)(4) 2013 FROM QUERY - AMENDED SIDE HIP: **LEFT, AMENDED IMPLANT DATE: (B)(6) 2009, AMENDED REVISION DATE: REMOVED REVISION DATE AS YET TO BE REVISED, PLEASE SEE ATTACHED DOCUMENT. PLEASE NOTE ***REVISION REASON IS INVALID AS IT PREVIOUSLY REFERED TO THE RIGHT SIDE HIP.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - RIGHT HIP; REASON FOR REVISION: COMPONENT LOOSENING - FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78081 DEPUY ASR XL FEM IMP SIZE 45 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2750463

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention