BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 3895797 · Received June 26, 2014

    Report

    Report Number
    1818910-2014-22050
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 18, 2014
    Report Date
    August 22, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ASR REVISION REPORTED BY SALES REP, UNKNOWN HIP, REASON FOR REVISION: CUP LOOSENING. IMPLANT HOSPITAL: (B)(6).

    Description of Event or Problem · 1

    UPDATE REC'D 08/22/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN AND ELEVATED METAL IONS. DOB WAS IDENTIFIED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 09/09/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375023 ASR ACETABULAR CUPS 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD.-8010379 2274113

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention