BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL TAP SLV ADAP 12/14+8

    MDR report key: 2823288 · Received November 7, 2012

    Report

    Report Number
    1818910-2012-24464
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    July 10, 2012
    Report Date
    November 27, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    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

    CORRECTED/UPDATED DATA: (DATE OF EVENT); (DATE OF REPORT); (EVENT DESCRIPTION); (MANUFACTURER); (EXPLANT DATE); (MANUFACTURING SITE); (DATE RECEIVED BY MANUFACTURER). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL ACETABULAR SYSTEM (LEFT); ASR XL ACETABULAR SYSTEM (RIGHT) ; REASON(S) FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE ASR LEFT HIP IMPLANT. THE REASON FOR THE REVISION WAS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR XL TAP SLV ADAP 12/14+8 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2396195

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention