BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6IN AML SM STATURE 12.0MM

    MDR report key: 2162261 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12025
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K061833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2009, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER LEFT SIDE. THE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PATIENTS ACETABULUM, CAUSING SEVERE PAIN, INHIBITING PATIENTS ABILITY TO WALK, CREATING ALARMING CLICKING NOISES, AND CAUSING ELEVATED BLOOD LEVELS OF CHROMIUM AND COBALT. PATIENT IS SCHEDULED TO UNDERGO A REVISION SURGERY ON OR ABOUT (B)(6) 2011. **UPDATE** 6/7/011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED TO ADDRESS HIP PAIN. **UPDATE** 8/29/11 - 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

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6), 2009, PT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER LEFT SIDE. THE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PT'S ACETABULUM, CAUSING SEVERE PAIN, INHIBITING PT'S ABILITY TO WALK, CREATING ALARMING CLICKING NOISES, AND CAUSING ELEVATED BLOOD LEVELS OF CHROMIUM AND COBALT. UPDATE: (B)(6) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PT WAS REVISED TO ADDRESS HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6IN AML SM STATURE 12.0MM 87LPH 87JDI LPH DEPUY ORTHOPAEDICS, INC. NA CC5F61000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention