BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +1.5

    MDR report key: 3800973 · Received May 8, 2014

    Report

    Report Number
    1818910-2014-18396
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 3, 2012
    Report Date
    June 27, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033615
    PMA / PMN Number
    K031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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 PAPERS ALLEGE: (B)(6) 2007, SHE HAD A LEFT HIP IMPLANTED, ON (B)(6) 2007 SHE HAD HER RIGHT HIP IMPLANTED. BUT, IN (B)(6) 2007 HER LEFT HIP BECAME DISLOCATED, AND BY (B)(6) OF 2008, HER RIGHT HIP IMPLANT BECOME DISLOCATED TWICE FOR WHAT SHE HAD A REDUCTION FOR. (B)(6) 2008, HAD A REVISION SURGERY DUE TO REPEATED DISLOCATION SHE EXPERIENCED WITH HER RIGHT HIP. (B)(6) 2008, HER RIGHT HIP DISLOCATED ON SEVERAL OCCASIONS THE SHE HAD TO HAVE HER HIP REDUCED AGAIN. SHE WAS FORCED TO HAVE ANOTHER REVISION SURGERY ON HER RIGHT HIP (B)(6) 2010. UPDATE REC'D (B)(6) 2012 - PATIENT WAS REVISED TO ADDRESS LACK OF RANGE OF MOTION AND STABILITY. UPDATE REC¿D (B)(6) 2012 ¿ PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. A DOR FROM THE LEFT HIP WAS GIVEN. THE UNKNOWN HIP AND UNKNOWN LINER IS BEING CHANGED TO THE HEAD AND LINER FROM THE LEFT PRIMARY FOR DISLOCATION, PAIN, AND POPPING ISSUES. THE UNKNOWN HEAD IS BEING CHANGED TO HEAD FROM THE RIGHT PRIMARY AND A LINER IS BEING ADDED AS WELL FOR DISLOCATION, PAIN, AND POPPING. A NEW COMPLAINT WILL BE ENTERED FOR THE SECOND REVISION OF THE RIGHT SIDE. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON : (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277191 DELTA CER HEAD 12/14 36MM +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 2382842 10603295033615

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Death| R