BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL TAP SLV ADAP 12/14+5

    MDR report key: 2810375 · Received October 31, 2012

    Report

    Report Number
    1818910-2012-24410
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 21, 2012
    Manufacturer
    DEPUY IRELAND
    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

    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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT (B)(4). REASON FOR ORIGINAL COMPLAINT ASR REVISION DUE TO TAKE PLACE ON (B)(6) 2012. ASR XL ACETABULAR SYSTEM - LEFT SEE BELOW FOR UPDATE. REASON(S) FOR REVISION: UNKNOWN. UPDATE- CHANGED CUP AND HEAD TO THE CORRECT PRODUCTS AND ADDED A SLEEVE, UPDATED SURGEON AND DATE OF REVISION, ALL TAKEN FROM CLAIMSUITE DATED (B)(6) 2012. UPDATE- UPDATED HIP TAKEN FROM CLAIMSUITE DATED (B)(6) 2012. RIGHT HIP. 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

    ASR REVISION, ASR XL ACETABULAR SYSTEM - RIGHT, REASON(S) FOR REVISION: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR XL TAP SLV ADAP 12/14+5 ASR TOTAL HIP REPLACEMENT KWA DEPUY IRELAND 2092447

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention