BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*LINR M SERIES,10DEG,26MM

    MDR report key: 6034166 · Received October 17, 2016

    Report

    Report Number
    1818910-2016-29472
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    March 17, 2013
    Report Date
    April 8, 2013
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LPH
    PMA / PMN Number
    K924492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO BONE FRACTURE AND IMPLANT WEAR. DOI- (B)(6) 2002, DOR-(B)(6) 2013. ON (B)(6) 2002, THA WAS DONE WITH S-ROM A. AFTER IMPLANTATION, THE PATIENT FELL OVER AND GREAT TROCHANTERIC FRACTURE OCCURRED. IN THE X-RAY, THE LINER WAS FOUND WORN. ON (B)(6) 2013, THE STEM AND THE LINER WERE REPLACED. TIME OF SURGERY WAS EXTENDED BY 60 MINUTES. ON (B)(6) 2013 (B)(6) ADVISED: IT WAS FOUND THAT THE FEMORAL FRACTURE WAS MORE SERIOUS THAN EXPECTED, AND THE STEM WAS REPLACED BY A NEW PRODUCT THOUGH THE STEM REPLACEMENT WAS NOT PLANNED BEFORE SURGERY. THAT MADE THE SURGERY EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686111 S-ROM*LINR M SERIES,10DEG,26MM HIP ACETABULAR INSERT/LINER LPH DEPUY IRELAND 9616671 1018025

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention