BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2499822 · Received March 22, 2012

    Report

    Report Number
    1818910-2012-06620
    Event Type
    Injury
    Date Received
    March 22, 2012
    Report Date
    January 9, 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
    CA, 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. REF. WWCAPA (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

    ADDED: BIRTH DATE, BRAND NAME, COMMON DEVICE NAME, CATALOG #/LOT #, PMA/510(K) #, IF FOLLOW-UP, WHAT TYPE, MANUFACTURE DATE. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING, BUT NOT LIMITED TO, PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, HIGH LEVELS OF TOXIC METAL IN HIS BLOOD STREAM, CONSCIOUS PAIN AND SUFFERING, AND LOSS OF EARNINGS.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2014 - MEDICAL RECORDS RECEIVED. PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS PSEUDOTUMOR, FLUID AND BROWN STAINING. PATIENT'S LEFT HIP WAS REVISED TO ADDRESS OSTEOLYSIS, AND WEAR ON THE STEM AND SLEEVE. THE LEFT SIDE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - SALES REP REPORTED REVISION DUE TO LOOSENING OF THE ACETABULAR CUP. FLUID WAS NOTICED INOPERATIVE. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2539341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other