BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 4233692 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31379
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 9, 2014
    Manufacturer
    DEPUY INTL., 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
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. 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). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP; ASR XL; LEFT; REASON(S) FOR REVISION : PAIN / LOOSENING (CUP). UPDATE REC'D 08/25/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES ELEVATED METAL ION LEVELS. THE EXISTING MDR DECISION HAS BEEN REVERSED AND THE FEMORAL HEAD HAS BEEN REPORTED. THE COMPLAINT WAS UPDATED ON: 09/18/2014. UPDATE REC¿D 09/08/2014 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WITH MEDICAL RECORDS WAS RECEIVED, WHICH IDENTIFIED DOI AND DOR INFORMATION. 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: 09/23/2014. UPDATE REC'D 10/09/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, PATIENTS INSTABILITY OF THE LEGS, AND ELEVATED METAL ION LEVELS. THE SLEEVE WILL BE REPORTED. THE STEM IS BEING ADDED TO THE COMPLAINT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 11/06/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714514 ADAPTER SLEEVES 12/14 +2 HIP OTHER IMPLANT KWA DEPUY INTL., LTD. - 8010379 2177802

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention