BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL TAP SLV ADAP 11/13+0

    MDR report key: 2974423 · Received February 22, 2013

    Report

    Report Number
    1818910-2013-02614
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    February 5, 2013
    Report Date
    August 21, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4), REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION RECOMMENDED. RIGHT. ASR XL. REASON(S) FOR REVISION: UNKNOWN. UPDATE- ADDED REVISION DATE TAKEN FROM CLAIMSUITE DATED (B)(6) 2013. UPDATE- ADDED HOSPITAL TAKEN FROM CLAIMSUITE DATED (B)(6) 2013 UPDATE - ADDED REASON FOR REVISION TAKEN FROM CLAIMSUITE DATED (B)(6) 2013. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    REASON FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    ASR REVISION;ASR XL - RIGHT HIP;REASON FOR REVISION: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78234 ASR XL TAP SLV ADAP 11/13+0 HIP OTHER IMPLANT KWA DEPUY INTERNATIONAL LTD. 8010379 1850837

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention