BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 3954218 · Received July 24, 2014

    Report

    Report Number
    1818910-2014-24122
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 4, 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
    DE, 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. REF. (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

    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

    SALES REP REPORTED REVISION SURGERY. XRAY AND PHOTOS PROVIDED. PATIENT HAS BEEN REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. UPON REVISION, CORROSION WAS FOUND ON THE HEAD AND SLEEVE. THE STEM WAS CLEANED AND REMAINED IN SITU. CERAMIC HEAD PLACED ON STEM. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Description of Event or Problem · 1

    UPDATE REC'D 8/4/2014- MAUDE REPORT 1821196486-2014-0002 RECEIVED. REPORT INDICATES PATIENT SUFFERED FROM SYNOVITIS, METALLOSIS WITH GRANULATION TISSUE, DISCOMFORT AND SWELLING. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 08/07/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433686 ASR UNI FEMORAL IMPL SIZE 45 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2850172

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention