BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR ACETABULAR IMPLANT 56

    MDR report key: 1940228 · Received December 23, 2010

    Report

    Report Number
    1818910-2010-09677
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    February 21, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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

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

    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. THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE US AT THIS TIME. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Description of Event or Problem · 1

    RECOMMENDED ASR REVISION - LEFT HIP.

    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; BI-LATERAL ASR XL ACETABULAR SYSTEM. UPDATE FROM (B)(4) SPREADSHEET (B)(4) 2011: HOSPITAL, HIP AFFECTED, DESC. UPDATE FOR BOTH SIDES- REVISON DATE, SURGERY DATE, REASON FOR REVISION, ADDITIONAL HOSPITAL AND SURGEON. IDENTIFIED PRODUCTS FOR BOTH SIDES. TAKEN FROM CLAIMSUITES X 2 DATED (B)(4) 2014. LEFT - 2195170; 2233154; 2222464. LEFT REV DATE - (B)(6) 2011. RIGHT - 2538591; 2498401; 2429791. RIGHT REV DATE - (B)(6) 2011. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2233154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention