BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2232359 · Received September 2, 2011

    Report

    Report Number
    1818910-2011-16874
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    May 31, 2012
    Report Date
    August 5, 2011
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, COMMON DEVICE NAME, CATALOG #/LOT #, EXPLANT DATE, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, IMPLANT DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE (B)(4) WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 2010, AND THE (B)(4) 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.

    Description of Event or Problem · 1

    BILATERAL PATIENT. LITIGATION PAPERS ALLEGE PATIENT SUFFERED FROM DISCOMFORT AND PAIN IN HER HIPS. IT IS ALSO ALLEGED IT BECAME INCREASINGLY PAINFUL FOR HER TO WALK, TO MOVE HER LEGS, TO STAND AND TO RISE FROM A SEATED POSITION. IT IS ALSO ALLEGED PATIENT SUFFERED A LOSS AND LIMITATION OR MOTION. IT IS ALSO ALLEGED PATIENT WILL UNDERGO REVISION SURGERY ON HER RIGHT HIP BY (B)(6) 2010. IT IS FURTHER ALLEGED PATIENT WILL HAVE TO GO UNDERGO A REVISION SURGERY FOR HER LEFT HIP AFTER HEALING FROM THE REVISION SURGERY ON HER RIGHT HIP. UPDATE: (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY FOR THE LEFT SIDE. PATIENT WAS REVISED DUE TO PAIN AND ELEVATED ION LEVELS.

    Description of Event or Problem · 1

    BILATERAL PATIENT. LITIGATION PAPERS ALLEGE PATIENT SUFFERED FROM DISCOMFORT AND PAIN IN HER HIPS. IT IS ALSO ALLEGED IT BECAME INCREASINGLY PAINFUL FOR HER TO WALK, TO MOVE HER LEGS, TO STAND AND TO RISE FROM A SEATED POSITION. IT IS ALSO ALLEGED PATIENT SUFFERED A LOSS AND LIMITATION OR MOTION. IT IS ALSO ALLEGED PATIENT WILL UNDERGO REVISION SURGERY ON HER RIGHT HIP BY (B)(6) 2010. IT IS FURTHER ALLEGED PATIENT WILL HAVE TO GO UNDERGO A REVISION SURGERY FOR HER LEFT HIP AFTER HEALING FROM THE REVISION SURGERY ON HER RIGHT HIP.

    Description of Event or Problem · 1

    BILATERAL PATIENT. LITIGATION PAPERS ALLEGE PATIENT SUFFERED FROM DISCOMFORT AND PAIN IN HER HIPS. IT IS ALSO ALLEGED IT BECAME INCREASINGLY PAINFUL FOR HER TO WALK, TO MOVE HER LEGS, TO STAND AND TO RISE FROM A SEATED POSITION. IT IS ALSO ALLEGED PATIENT SUFFERED A LOSS AND LIMITATION OR MOTION. IT IS ALSO ALLEGED PATIENT WILL UNDERGO REVISION SURGERY ON HER RIGHT HIP BY (B)(6) 2010. IT IS FURTHER ALLEGED PATIENT WILL HAVE TO GO UNDERGO A REVISION SURGERY FOR HER LEFT HIP AFTER HEALING FROM THE REVISION SURGERY ON HER RIGHT HIP. UPDATE: (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY FOR THE LEFT SIDE. PATIENT WAS REVISED DUE TO PAIN AND ELEVATED ION LEVELS. UPDATE: (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FOR THE RIGHT SIDE AND ALSO IDENTIFIED IMPLANT DATES FOR BOTH SIDES. 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

    AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY WITH LARGE METAL ON METAL BEARING SURFACE PLUS INFLAMMATORY REACTION DUE TO METALOSIS CAUSING ACUTE INFLAMMATORY EFFUSION. OPERATIVE FINDINGS REPORTED INFLAMMATORY CLOUDY JOINT FLUID THAT APPEARED FLUID OF METALLOSIS, SYNOVIAL TISSUES WERE INFLAMED AND HYPERTROPHIC. THERE WAS A REGION OF OSSIFICATION IN THE SUBCUTANEOUS FAT JUST ABOVE THE IT BAND WHICH REQUIRED TUNNELING OF THE INCISION IN A SUBCUTANEOUS IN-ORDER TO RETRIEVE. THERE WERE 2 HETEROTOPIC BONY MASSES. MORSE TAPER FOUND TO HAVE SOME BLACK MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2152083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention