BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2980716 · Received February 27, 2013

    Report

    Report Number
    1818910-2013-01651
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    September 18, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    ATTORNEY

    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. (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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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 INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE:PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS RIGHT SIDE ON OR ABOUT (B)(6) 2007. PATIENT EXPERIENCED METAL IONS IN HIS BODY, PAIN, DISTRESS, ANXIETY, AND LIMITATION OF MOVEMENT. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE REC'D 9/18/2014 CLINICAL SPREADSHEET RECEIVED. CLINICAL NUMBER, WEIGHT AND HEIGHT PROVIDED. PATIENT EXPERIENCED SOFT TISSUE CHANGES AND OSTEOLYSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 03/11/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84364 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2192981

    Patients

    Seq Age Sex Outcome Treatment
    1 Other