BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18D-LRG

    MDR report key: 2901831 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-00794
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 2, 2009
    Report Date
    December 12, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC USA
    Product Code
    LPH
    PMA / PMN Number
    K934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE AFTER THE SURGERY, PATIENT EXPERIENCED SEVERE PAIN AND INFLAMMATION IN HIS RIGHT HIP, THIGH AND GROIN AREA AND SEVERE PAIN WHILE WALKING. IT IS FURTHER ALLEGED PATIENT ALSO EXPERIENCED AN AUDIBLE POPPING AND LOOSENING SENSATION IN HIS RIGHT HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. IT IS ALSO ALLEGED PATIENT EXPERIENCED NUMBNESS ALONG THE OUTSIDE IN HIS RIGHT LEG. UPDATE: (B)(4) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE FEMORAL STEM WAS GROSSLY LOOSE. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9152 S-ROM*SLEEVE PRX ZTT, 18D-LRG DEPUY SLEEVE LPH DEPUY ORTHOPAEDICS INC USA 1073879

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention