BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 3822327 · Received May 20, 2014

    Report

    Report Number
    1818910-2014-19171
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 29, 2014
    Report Date
    August 6, 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 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 THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.ADDITIONAL NARRATIVE: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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ASR REVISION REPORTED BY SALES REP.RIGHT SIDE HIP.REASON(S)FOR REVISION: UNKNOWN.ASR COMPONENT REMOVED AND REPLACED WITH PINNACLE SECTOR / ALTRX POLY / COCR FEMORAL HEAD. EXPLANTS WERE RETAINED BY HOSPITAL RISK MANAGEMENT.

    Description of Event or Problem · 1

    UPDATE REC'D 08/06/2014 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOI INFORMATION FROM PATIENT STICKER SHEET. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 08/12/2014.

    Description of Event or Problem · 1

    UPDATE REC¿D 7/8/2014 - LITIGATION RECEIVED. LITIGATION ALLEGES INJURY TO THE BODY AND EXTREMITIES, PAIN, AND ELEVATED METAL ION LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON:07/16/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298476 ASR ACETABULAR CUPS 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD.-8010379 2238215

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention