BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2113185 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08894
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    November 29, 2010
    Report Date
    April 21, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: PATIENT WAS REVISED TO ADDRESS ACETABULAR LOOSENING. DOI: UNK - DOR: (B)(6) 2010. UPDATE: (B)(4) 2011 - LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) 2008-PRESENT, PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJUR(IES) AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: CONSTANT PAIN, INABILITY TO LEAD A NORMAL LIFE, POSSIBLE NICKEL AND COBALT POISONING, REVISION SURGERIES, NUMEROUS DOCTOR VISITS AND FUTURE HIP PROBLEMS. FEMORAL HEAD ADDED TO THE COMPLAINT. DOI IDENTIFIED IN LITIGATION PAPERS - (B)(6) 2008. PATIENTS DOB IDENTIFIED IN LITIGATION PAPERS. PATIENT IS A RESIDENT OF (B)(6). 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.

    Additional Manufacturer Narrative · 1

    UPDATE - (B)(4) 2012 PATIENT FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED LOT INFORMATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    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

    PATIENT WAS REVISED TO ADDRESS ACETABULAR LOOSENING. UPDATE: (B)(6) 2011- LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) 2008, PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURY(IES) AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT. CONSTANT PAIN, INABILITY TO LEAD A NORMAL LIFE, POSSIBLE NICKEL AND COBALT POISONING, REVISION SURGERIES, NUMEROUS DOCTOR VISITS AND FUTURE HIP PROBLEMS. FEMORAL HEAD ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL, LTD. NA 2483650

    Patients

    Seq Age Sex Outcome Treatment
    1 57 DA Required Intervention