BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL TAP SLV ADAP 12/14+2

    MDR report key: 2802093 · Received October 23, 2012

    Report

    Report Number
    1818910-2012-23849
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    December 19, 2011
    Report Date
    May 16, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    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

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

    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.

    Description of Event or Problem · 1

    ASR REVISION, TYPE OF HIP REPLACEMENT PRODUCT HIP : UNKNOWN. REASON(S) FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. TYPE OF HIP REPLACEMENT PRODUCT & HIP : UNKNOWN. REASON(S) FOR REVISION: UNKNOWN. UPDATE- ADDED CUP, HEAD AND SLEEVE FROM CLAIMSUITE EMAIL DATED (B)(4) 2012. UPDATE - ADDED HIP SIDE, TYPE OF REPLACEMENT, REASON FOR REVISION AND AMENDED REVISION DATE. TAKEN FROM CLAIMSUITE DATED 16TH MAY 2014. LEFT; ASR XL. REASON(S) FOR REVISION: PAIN. UPDATE - AMENDED ORIGINAL SURGERY DATE. TAKEN FROM CLAIMSUITE DATED 28TH MAY 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR XL TAP SLV ADAP 12/14+2 23849 KWA DEPUY INTERNATIONAL LTD. 8010379 1221318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention