BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 2152165 · Received June 24, 2011

    Report

    Report Number
    1818910-2011-11341
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    June 2, 2011
    Report Date
    January 22, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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. WWCAPA (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT DATE, EVENT DESCRIPTION, CONTACT INFORMATION. DEPUY STILL 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 PREVIOUSLY 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.

    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.

    Description of Event or Problem · 1

    THE PT IS SCHEDULED FOR AN ASR REVISION (B)(6), 2011. SPECIFIC DETAILS REGARDING THE REPORT ARE UNK.

    Description of Event or Problem · 1

    UPDATE: REASON FOR REVISION AND DATE OF REVISION CONFIRMATION RECEIVED ON (B)(4) 2012. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    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, ASR XL ACETABULAR SYSTEM (LEFT). UPDATE: REASON FOR REVISION AND DATE OF REVISION CONFIRMATION RECEIVED ON 29 MAY 2012. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE - ADDED HEAD AND SLEEVE, QUERYING MISSING STEM. TAKEN FROM CLAIMSUITE DATED 22ND JAN 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 1195503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention