BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 3180426 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-06909
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    November 10, 2014
    Report Date
    November 10, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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. 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 STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON (B)(6) 2007, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT IN HER RIGHT HIP. SHE EXPERIENCED INJURIES, PAIN, AND SUFFERING. SHE WILL HAVE TO UNDERGO REVISION SURGERY. PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT, LITIGATION PAPERS ALLEGE: ON (B)(6) 2007, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT IN HER RIGHT HIP. SHE EXPERIENCED INJURIES, PAIN, AND SUFFERING. SHE WILL HAVE TO UNDERGO REVISION SURGERY. DOI: (B)(6) 2007 - DOR: UNK (RIGHT SIDE). **PATIENT IS A RESIDENT OF (B)(6). **UPDATE*** 05/21/2012 OF PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. DOB ADDED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. PRODUCT HIP TO CUP, ADDED HEAD. **UPDATE** 10 NOV 2014 - DER RCVD. ADDED DOR, STEM AND SLEEVE DETAILS, SALES REP AND SURGEON INFORMATION AND OSTEOLYSIS AS A REASON FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280570 ASR UNI FEMORAL IMPL SIZE 45 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2357740

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R