BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 2983541 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-02928
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 21, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    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. (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

    THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, CLICKING, INSTABILITY, ELEVATED METAL LEVELS IN BLOOD; AND ABILITY TO WALK AND MOVE HAS BEEN INHIBITED, REQUIRING USE OF CANE AND SCOOTER AFTER ASR HIP IMPLANT. **UPDATE** ((B)(4) 2013) - PATIENT FACT SHEET WAS RECEIVED. THE DOR (RIGHT) HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THERE IS A DISCREPANCY WITH THE DOR FOR THE RIGHT SIDE. PART & LOT HAVE BEEN IDENTIFIED BY PATIENT STICKER SHEET. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, CLICKING, INSTABILITY, ELEVATED METAL LEVELS IN BLOOD; AND ABILITY TO WALK AND MOVE HAS BEEN INHIBITED, REQUIRING USE OF CANE AND SCOOTER AFTER ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85821 ASR ACETABULAR CUPS 48 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2773060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention