BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2071457 · Received April 13, 2011

    Report

    Report Number
    1818910-2011-06156
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    November 10, 2010
    Report Date
    March 14, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: PATIENT CONTACTED (B)(4) TO INITIATE CLAIM. PATIENT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOR: (B)(6) 2010 (LEFT SIDE). UPDATE: 03/14/2011 - LITIGATION PAPERS ALLEGE PATIENT DEVELOPED A MASS ON HER THIGH KNOWN AS A PSEUDO TUMOR, THE ASR SYSTEM CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PATIENTS ACETABULUM, CAUSING AN INFLAMMATORY PROCESS AND BONE DETERIORATION AND LOSS (ACETABULAR BONE LOSS). IT IS ALSO ALLEGED THE PATIENT SUSTAINED SEVERE PAIN, THE DEVICE INHIBITED HER ABILITY TO WALK, AND PATIENT REQUIRED A REVISION SURGERY. DOI: (B)(6) 2008 - (B)(6) 2010. PATIENT IS A RESIDENT OF (B)(6). UPDATE: PATIENT WAS REVISED TO ADDRESS PAIN, LOOSENING AND METALLOSIS. THE SALES REP WAS AWARE OF THIS INFORMATION AT THE TIME OF REVISION; HOWEVER, IT WAS REPORTED TO DEPUY LATE AND IS NOW BEING UPDATED TO THE COMPLAINT. AN ADDITIONAL PRODUCT PAGE WAS ADDED TO THE COMPLAINT. 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. WWCAPA (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 STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT CONTACTED BROADSPIRE TO INITIATE CLAIM. PT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. UPDATE: (B)(6) 2011 - LITIGATION PAPERS ALLEGE PT DEVELOPED A MASS ON HER THIGH KNOWN AS A PSEUDO TUMOR, THE ASR SYSTEM CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM THE PT'S ACETABULUM, CAUSING AN INFLAMMATORY PROCESS AND BONE DETERIORATION AND LOSS (ACETABULAR BONE LOSS). IT IS ALSO ALLEGED THE PT SUSTAINED SEVERE PAIN, THE DEVICE INHIBITED HER ABILITY TO WALK, AND PT REQUIRED A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR FEMORAL HEAD NONE KXA DEPUY INTERNATIONAL, LTD. NA 2559660

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention