BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3954049 · Received July 23, 2014

    Report

    Report Number
    1818910-2014-24104
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 8, 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
    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. 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. DEPUY CONSIDERS THE INVESTIGATION COMPLETED. SHOULD FURTHER INFORMATION BE RECEIVED, THE COMPLAINT WILL BE UPDATED AT THAT TIME.

    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.

    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 CASE CLOSED TO CAPA.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES EXCESSIVE LEVELS OF CHROMIUM AND COBALT, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. PATIENT IS BILATERAL.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2017 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, SCARRING WITHIN THE ADIPOSE TISSUE AREA, BLACK AND CLOUDY FLUID IN THE JOINTS, SYNOVIAL OVERGROWTH, AND ELEVATED COBALT AND CHROMIUM LEVELS. COBALT LEVEL WAS 18.7 MCG/L. INTRAOPERATIVE FINDINGS REVEALED MARKED CHANGES MOST CONSISTENT WITH WEARING OF THE ANTERIOR COLUMN AND DEFICIENCY WHICH WAS GRAFTED WITH LOCAL GRAFT. THERE WAS ALSO EVIDENCE THAT THIS WAS CHANGES OF THE SYNOVIAL TISSUE CONSISTENT FOR METAL DEBRIS. THIS COMPLAINT WAS UPDATED ON (B)(6) 2017.

    Description of Event or Problem · 1

    **UPDATE 12/14/2015** PPD RECEIVED. PATIENT DOB WAS UPDATED. THE PART/LOT INFORMATION FOR THE CUP AND HEAD WAS PROVIDED FROM THE PATIENT STICKER SHEET. THE COMPLAINT WAS UPDATED ON 12/21/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430325 ASR UNI FEMORAL IMPL SIZE 51 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2177223

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other