BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 2

    MDR report key: 1924898 · Received December 8, 2010

    Report

    Report Number
    9616680-2010-00812
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K891454
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA THE SALES REP THAT BACK IN 2003, A MALE PT REC'D IMPACTION GRAFTING SURGERY USING THE EXETER 44 FEMORAL STEM. IT HAS BEEN REPORTED THAT THE SAME PT NEEDED A REVISION SURGERY WHICH WAS CARRIED OUT 3 WEEKS AGO BECAUSE THE SURGEON REPORTED VIA THE SALES REP THAT THE ORIGINAL IMPLANT HAD FRACTURED. IT WAS REPORTED THAT THE PT WAS VERY MUSCULAR AND STOCKY. IT HAS ALSO BEEN REPORTED BY THE SALES REP THAT THE SURGEON COMMENTED THAT HE HAD SEEN FAILURES BEFORE IN PT TYPES WHO WERE MUSCULAR AND STOCKY. THE SURGEON ALSO COMMENTED THAT HE BELIEVES THE REASON FOR THE FRACTURE IS DUE TO THE PT TYPE AND THE IMPACTION GRAFTING TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 44MM NO 2 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA GB733965

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention