BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 54

    MDR report key: 3050245 · Received April 10, 2013

    Report

    Report Number
    1818910-2013-04707
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - LEFT HIP; REASON(S) FOR REVISION: COMPONENT LOOSENING; PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148216 ASR ACETABULAR IMPLANT 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL 2491610

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention