BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2851804 · Received November 29, 2012

    Report

    Report Number
    1818910-2012-24216
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2011
    Report Date
    November 10, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE 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. (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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2013 - CLINICAL REPORT WAS RECEIVED. CLINICAL REPORT INDICATES THE PATIENT WAS REVISED TO ADDRESS A FOCAL HISTOLYTIC INFLAMMATORY REACTION, INTERMITTENT NUMBNESS AND GROIN PAIN, AND LOCAL TISSUE REACTIONS. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO A CLOUDY EFFUSION, STAIN AND DEBRIS IN THE PERIARTICULAR AREA, BROWN/GRAY DEBRIS IN THE FEMORAL HEAD RECESS, A THICKENED, DRY CAPSULE AND CORROSION ON THE TRUNNION. THE FEMORAL STEM AND ADAPTER SLEEVE HAVE BEEN ADDED TO THE COMPLAINT.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT SOMETIME AFTER IMPLANTATION, THE PATIENT WAS ADVISED THAT HER IMPLANT WAS FAILING AND THAT SHE HAD HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN HER BLOOD. THE PATIENT WAS REVISED. ADDITIONALLY, LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED INJURIES OF A PERMANENT NATURE; ENDURED PAIN AND SUFFERING AND IS UNABLE TO ATTEND TO HER NORMAL AFFAIRS AND DUTIES FOR AN INDEFINITE PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2837191

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention