BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 2

    MDR report key: 2234046 · Received August 29, 2011

    Report

    Report Number
    9616680-2011-00565
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 9, 2011
    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

    THE SURGEON REPORTED THAT AN EXETER STEM HAD SNAPPED AT THE TRUNNION. HE ADDED THAT THE INITIAL IMPLANTATION TOOK PLACE IN (B)(6) 2006, THE REVISION ON THE (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 44MM NO 2 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA G1407080

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention