BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ASR FEM IMP SIZE 53

    MDR report key: 1914965 · Received November 17, 2010

    Report

    Report Number
    1818910-2010-07907
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    February 11, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH, THE SPECIFIC NATURE OF THE PT'S COMPLAINT IS UNK, BECAUSE REVISION HAS BEEN RECOMMENDED BY DEPUY'S THIRD-PARTY CLAIMS ADMINISTRATOR, IT IS REASONABLE TO CONCLUDE THAT THE PT'S COMPLAINT HAS BEEN DETERMINED TO BE PRODUCT-RELATED. 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. REF. WWCAPA (B)(4).

    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

    ASR REVISION RECOMMENDED.

    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, LEFT ASR HIP RESURFACING SYSTEM, REASON FOR REVISION: PAIN. UPDATE FROM (B)(6) SPREADSHEET 8TH NOV 2011: REASON FOR REVISION, LOT NO, DESC. UPDATE REC'D 11 FEB 2014 - ADDED FORM 57.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 53 HIP KWA DEPUY INTL., LTD. - 8010379 NA 2643398

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention