BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER MOD RASP SIZE 1 44/50MM

    MDR report key: 2226767 · Received August 24, 2011

    Report

    Report Number
    2249697-2011-01233
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) AFTERNOON (B)(6) 2011, SALES REP RECEIVED A PHONE CALL FROM THE ORTHOPAEDIC THEATRE NURSE MANAGER AT (B)(6), SEEKING ADVICE AS TO HOW TO BEST REMOVE A MODULAR 50MM EXETER NO. 1 RASP WHICH HAD BECOME LODGED IN A PT'S PROXIMAL FEMUR DURING FEMORAL BROACHING. THE LOCKING TAB ON THE BROACH HAD BROKEN OFF DURING USE BY MR (B)(6) THE SURGEON CONFIRMED THAT HE WOULD BE ABLE TO CLEAR SOME BONE AND SOFT TISSUE ABOVE THE RASP. THIS ALLOWED THE EDGE OF A BRISTOW ELEVATOR TO BE INSERTED TO ENGAGE THE MOST PROXIMAL CUTTING TEETH OF THE RASP. THE RASP WAS CAREFULLY TAPPED BACK OUT AND THE HIP REPLACEMENT COMPLETED WITH ANOTHER RASP. ANOTHER 50MM EXETER NO.1 RASP WAS USED TO COMPLETE THAT PHASE OF THE HIP REPLACEMENT. THIS WAS UPSIZED TO A 50MM NO.2 RASP. AFTER TRAILING AND ASSESSMENT OF LEG LENGTH AND STABILITY- AN EXETER 50MM NO.2 STEM WAS IMPLANTED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER MOD RASP SIZE 1 44/50MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA TDCE607

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention