BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 4950005 · Received July 29, 2015

    Report

    Report Number
    1818910-2015-26841
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    April 30, 2015
    Report Date
    August 5, 2015
    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
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS FOUND DURING THE REVISION OPERATIVE NOTE THE LITIGATION ALLEGES DISCOMFORT, CLICKING, AND GRINDING. THE TAPER SLEEVE IS NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2016. (B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    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. 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.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LEGAL CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT UNDERWENT A LEFT HIP REPLACEMENT ON (B)(6) 2008 AND HAD ASR IMPLANTS IMPLANTED. THE PATIENT WAS REVISED ON (B)(6) 2015 FOR PAIN, INCREASED METAL IONS, AND CORROSION ON THE TAPER. NO LABS WERE PROVIDED FOR THE INCREASED METAL IONS.

    Description of Event or Problem · 1

    LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS FOUND DURING THE REVISION OPERATIVE NOTE THE LITIGATION ALLEGES DISCOMFORT, CLICKING, AND GRINDING. THE TAPER SLEEVE IS NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493800 ASR UNI FEMORAL IMPL SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTL.,LTD 8010379 2597142

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention