BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2162241 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12032
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE THE PATIENT HAS EXPERIENCED PERSISTENT PAIN AND DISCOMFORT IN HIS HIP, WHICH PAIN HAS CONTINUED UNTIL THE PRESENT DAY, AFFECTING HIS ABILITY TO WALK, AND CAUSING POTENTIAL UNNECESSARY AND ADDITIONAL SURGERIES AND OTHER INJURIES PRESENTLY UNDIAGNOSED. (B)(4). 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. (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

    THE REPORT STATES: LITIGATION PAPERS ALLEGE THE PATIENT HAS EXPERIENCED PERSISTENT PAIN AND DISCOMFORT IN HIS HIP, WHICH PAIN HAS CONTINUED UNTIL THE PRESENT DAY, AFFECTING HIS ABILITY TO WALK, AND CAUSING POTENTIAL UNNECESSARY AND ADDITIONAL SURGERIES AND OTHER INJURIES PRESENTLY UNDIAGNOSED. DOI: (B)(6) 2008 - NO REPORTED REVISION. UPDATE: (B)(6) 2011 - MEDICAL RECORDS RECEIVED. PART/LOT NUMBERS IDENTIFIED AND COMPLAINT UPDATED. DOI: (B)(6) 2008 (RIGHT HIP). 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. (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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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

    CORRECTED: LOT #. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT HAS EXPERIENCED PERSISTENT PAIN AND DISCOMFORT IN HIS HIP, WHICH PAIN HAS CONTINUED UNTIL THE PRESENT DAY, AFFECTING HIS ABILITY TO WALK, AND CAUSING POTENTIAL UNNECESSARY AND ADDITIONAL SURGERIES AND OTHER INJURIES PRESENTLY UNDIAGNOSED. UPDATE: (B)(4) 2011 - MEDICAL RECORDS RECEIVED. PART/LOT NUMBERS IDENTIFIED AND COMPLAINT UPDATED. UPDATE: (B)(4) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED CORRECT SIDE AND DATE OF REVISION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(4) 2012 - AN AUTHORIZATION TO PROVIDE EXPLANTS FORM AS WELL AS THE DECLARATION FOR SHIPPING FORM HAVE BEEN RECEIVED. THESE FORMS INDICATE THAT PATIENT WAS REVISED ON (B)(6) 2012. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT HAS EXPERIENCED PERSISTENT PAIN AND DISCOMFORT IN HIS HIP, WHICH PAIN HAS CONTINUED UNTIL THE PRESENT DAY, AFFECTING HIS ABILITY TO WALK, AND CAUSING POTENTIAL UNNECESSARY AND ADDITIONAL SURGERIES AND OTHER INJURIES PRESENTLY UNDIAGNOSED. UPDATE: (B)(6) 2011 - MEDICAL RECORDS RECEIVED. PART/LOT NUMBERS IDENTIFIED AND COMPLAINT UPDATED. UPDATE: (B)(6) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED CORRECT SIDE AND DATE OF REVISION. 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 THE PATIENT HAS EXPERIENCED PERSISTENT PAIN AND DISCOMFORT IN HIS HIP, WHICH PAIN HAS CONTINUED UNTIL THE PRESENT DAY, AFFECTING HIS ABILITY TO WALK, AND CAUSING POTENTIAL UNNECESSARY AND ADDITIONAL SURGERIES AND OTHER INJURIES PRESENTLY UNDIAGNOSED. UPDATE: (B)(6) 2011 - MEDICAL RECORDS RECEIVED. PART/LOT NUMBERS IDENTIFIED AND COMPLAINT UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 49 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2564448

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention