BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 0

    MDR report key: 2234044 · Received August 29, 2011

    Report

    Report Number
    9616680-2011-00561
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 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
    AS
    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 WAS REPORTED THAT SURGEON REVISED AN EXETER STEM FOR IMPLANT FRACTURE TODAY. THE NECK OF THE STEM AND THE HEAD WERE REMOVED ONCE THE SURGEON HAD ACCESS. THE SURGEON WAS THEN ABLE TO DRILL A HOLE INTO THE STEM AND REMOVE IT USING A PUNCH AND MALLET. HE IMPLANTED A 44 MM CEMENT IN CEMENT STEM AND PUT A 28MM DELTA V40 HEAD ON THE STEM. SURGEON STATED THAT THE EXETER STEM APPEARED TO HAVE FRACTURED THROUGH THE DIMPLE/DRIVE HOLE ON THE SHOULDER OF THE EXETER STEM. HE SAID THAT WHEN HE REVIEWED HIS OPERATION NOTES FROM THE ORIGINAL SURGERY IN 2005, HE HAD COMMENTED ON THE FACT THAT THE PT'S FEMORAL NECK WAS RETROVERTED 30 DEG AND THIS DID NOT ALLOW HIM TO PUT A LARGER THAN 44MM SIZE 0 EXETER STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 44MM NO 0 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA GB816221

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention