BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM STM STD 36+12L 13X18

    MDR report key: 3090048 · Received May 2, 2013

    Report

    Report Number
    1818910-2013-06535
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    August 8, 2011
    Report Date
    April 2, 2013
    Manufacturer
    DEPUY IRELAND
    Product Code
    LPH
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE FEMORAL STEM PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION 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. 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

    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

    (B)(4). 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

    LITIGATION PAPERS ALLEGE PATIENT HAS SUFFERED THE FOLLOWING PERSONAL INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: HIP PAIN AND WEAKNESS, ELEVATED LEVELS OF METAL IONS, DIZZINESS AND PROBLEMS WITH BALANCE, AND PROBLEMS STANDING, WALKING AND MOVING UP AND DOWN STAIRS. PATIENT WILL BE HAVING THE ASR HIP IMPLANT EXPLANTED ON (B)(6) 2011. **UPDATE** 04/02/2013 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS METALLOSIS. UPON REVISION BLACKENED DARK BURSA WAS ENCOUNTERED ALONG WITH CORROSION ON THE NECK. THE STEM AND SLEEVES WERE ADDED TO THE COMPLAINT AND THE COMPLAINT RE-OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191471 SROM STM STD 36+12L 13X18 STEM LPH DEPUY IRELAND 2173430

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention