BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2946177 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-02414
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 30, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (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.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, DIFFICULTY STANDING, WALKING, GOING DOWN INCLINES AND WALKING WITH AWKWARD GAIT; POPPING, CLICKING AND LEG WEAKNESS, BURNING IN HIP AND LEG, TINGLING IN LEG AND FOOT EXTREMELY PAINFUL AND ON FIRE WHICH ADVERSELY AFFECTS ABILITY TO PARTICIPATE IN DAILY ACTIVITIES; AND ELEVATED METAL IONS LEVELS AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, DIFFICULTY STANDING, WALKING, GOING DOWN INCLINES AND WALKING WITH AWKWARD GAIT; POPPING, CLICKING AND LEG WEAKNESS, BURNING IN HIP AND LEG, TINGLING IN LEG AND FOOT EXTREMELY PAINFUL AND "ON FIRE" WHICH ADVERSELY AFFECTS ABILITY TO PARTICIPATE IN DAILY ACTIVITIES; AND ELEVATED METAL IONS LEVELS AFTER ASR HIP IMPLANT. **UPDATE** (B)(4) 2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE 10/24/2019 SUPPLEMENTAL INFORMATION RECEIVED. PATIENT HAS BEEN REVISED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION OR THE INVESTIGATION. ADDING THE SLEEVE AND STEM FOR ELEVATED IONS.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL IONS. REVISION NOTE STATED, THE PATIENT HAS BEEN DEVELOPING PAIN IN HIS HIP WITHOUT EVIDENCE OF LOOSENING OF THE COMPONENTS. BOTH THE ACETABULAR AND FEMORAL COMPONENTS WERE WELL FIXED. THERE WERE NO OBVIOUS AND ADVERSE TISSUE REACTION WITH NO PSEUDOTUMOR OR NO DESTRUCTION OF THE ABDUCTOR TENDONS. DOI: (B)(6) 2009 : DOR: (B)(6) 2016 (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49644 ASR UNI FEMORAL IMPL SIZE 51 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD. 8010379 2761777

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other