BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT DUOFIX TAP SZ5 STD OFF

    MDR report key: 2881520 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-28468
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    June 21, 2011
    Report Date
    December 7, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K011489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE PROVIDED FEMORAL STEM PRODUCT/LOT CODE COMBINATION FINDS NO OTHER REPORTS OF CORROSION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. IT IS KNOWN 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. UPDATE PATIENTS OPERATIVE REPORTS RECEIVED. RECORDS INDICATE UPON REVISION MILD CORROSION WAS NOTED AROUND THE MORSE TAPER. THE STEM AND SLEEVE WERE ADDED TO THE PRODUCT PAGES AND THE COMPLAINT RE-OPENED. UPDATE LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, A LACK OF MOBILITY AND OTHER INJURIES DUE TO THE EXCESSIVE LEVELS OF CHROMIUM AND COBALT. THERE IS NO NEW INFORMATION THAT CHANGES THE OUTCOME OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. (B)(4) 2012 - PATIENTS OPERATIVE REPORTS RECEIVED. RECORDS INDICATE UPON REVISION MILD CORROSION WAS NOTED AROUND THE MORSE TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT DUOFIX TAP SZ5 STD OFF STEM LPH DEPUY WARSAW A53DN1000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR