BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL TAP SLV ADAP 12/14+2

    MDR report key: 3120131 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-05829
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 7, 2010
    Report Date
    May 8, 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
    ATTORNEY

    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. REF. (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

    ADDITIONAL NARRATIVE: 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

    ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE DEVICE IS NOT CONTRIBUTING TO THE ISSUE; THEREFORE, THIS REPORT IS BEING REJECTED.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL - RIGHT, REASON FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222377 ASR XL TAP SLV ADAP 12/14+2 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2584726

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention