BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2241673 · Received September 9, 2011

    Report

    Report Number
    1818910-2011-17638
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 10, 2011
    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
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ACHES AND PAIN IN HER RIGHT HIP, PAIN WHEN LYING ON HER RIGHT SIDE, AUDIBLE CLICKING WHEN TURNING OVER IN BED, STIFFNESS AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, AND ELEVATED LEVELS OF CHROMIUM AND COBALT BY BLOOD TEST DATED (B)(6), 2011.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ACHES AND PAIN IN HER RIGHT HIP, PAIN WHEN LYING ON HER RIGHT SIDE, AUDIBLE CLICKING WHEN TURNING OVER IN BED, STIFFNESS AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, AND ELEVATED LEVELS OF CHROMIUM AND COBALT BY BLOOD TEST DATED (B)(6) 2011. UPDATE: (B)(6) 2011, PLAINTIFFS PRELIMINARY DISCLOSURE (PPD) FORM RECEIVED (B)(6) 2011. LABS (B)(6) 2010, CHROMIUM 2.9NG/ML (REF 1.0) COBALT 8.2NG/ML (REF 1.8NG/ML). THERE WAS NO NEW INFORMATION RECEIVED THAT WOULD IMPACT THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2013 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DATE OF REVISION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2522200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention