BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 16D-SML

    MDR report key: 2960909 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-03798
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 12, 2011
    Report Date
    January 28, 2013
    Manufacturer
    DEPUY IRELAND
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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

    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).

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, DISABILITY, IMPAIRMENT, DISFIGUREMENT, AGGRAVATION OF A PRE-EXISTING CONDITION AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP. UPDATE: (B)(4) 2012 - PATIENT FACT SHEET 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. UPDATE: (B)(4) 2013 - MEDICAL RECORDS WERE OBTAINED. RECORDS INDICATED FEMORAL COMPONENT WAS GROSSLY LOOSE, SYNOVITIS AND MURKY COLORED FLUID WAS NOTED INTEROPERIVATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65185 S-ROM*SLEEVE PRX ZTT, 16D-SML SLEEVE MRA DEPUY IRELAND 2439610

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention