BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 58

    MDR report key: 2261086 · Received September 23, 2011

    Report

    Report Number
    1818910-2011-18798
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    October 12, 2010
    Report Date
    May 30, 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
    NZ
    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).

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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

    REASON(S) FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    NEW (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (LEGACY SYSTEM) COMPLAINT NUMBER (B)($) REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR XL ACETABULAR SYSTEM - RIGHT. REASON(S) FOR REVISION: UNKNOWN. UPDATE - ADDED (B)(6) SPREADSHEET AND MARKED AS LEGAL. DATED 30TH MAY 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 58 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2450595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention