BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 4241942 · Received November 10, 2014

    Report

    Report Number
    1818910-2014-31487
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    September 4, 2014
    Report Date
    November 13, 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
    NY, US
    Reporter Occupation
    ATTORNEY

    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. (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

    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 ALLEGES PAIN, STIFFNESS, DISCOMFORT, EXCESSIVE LEVELS OF CHROMIUM AND COBALT AND WEAKNESS. UPDATE DER RCVD. ADDED DOR, SURGEON, SALES REP INFO AND PATIENT AGE. ADDED LOOSENING (CUP) AND OSTEOLYSIS TO REASONS FOR REVISION. ADDED SLEEVE AND UNKNOWN STEM AS LOT NUMBER PROVIDED FOR STEM IS INCORRECT/INCOMPATIBLE. UPDATE REC¿D 10/17/2014 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 11/10/2014.

    Description of Event or Problem · 1

    UPDATE REC¿D 11/13/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, BLACK STAINED SYNOVIAL FLUID, TROCHANTERIC BURSITIS, METALLOSIS, GRANULOMATOUS TISSUE, CYSTIC REGIONS IN THE ACETABULUM, AND CORROSION WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 12/05/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723958 ADAPTER SLEEVES 12/14 +2 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL., LTD. - 8010379 2601800

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention