BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3895805 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-22048
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 25, 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
    GA, 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. 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.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    UPDATE REC'D 7/16/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS OSTEOLYSIS. UPON REVISION, YELLOW FLUID, FIBRINOUS TAN DEBRIS WITHIN THE POSTERIOR ASPECT OF THE FEMORAL HEAD, AND CORROSION ON THE TRUNNION WERE NOTED. THE SLEEVE IS NOW BEING REPORTED. STEM REMAINED IN SITU, AND IS BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 07/28/2014.

    Description of Event or Problem · 1

    UPDATE REC¿D 07/25/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES ELEVATED METAL IONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 08/05/2014.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP, RIGHT, REASON(S) FOR REVISION : PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371042 ASR UNI FEMORAL IMPL SIZE 51 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD.-8010379 2420403

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention