BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACETABULAR REAMER 51MM

    MDR report key: 3264928 · Received July 26, 2013

    Report

    Report Number
    9614497-2013-00002
    Event Type
    Other
    Date Received
    July 26, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL, INC.
    Product Code
    HWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE 51MM REAMER FAILED OR MALFUNCTION DURING THE PROCEDURE. CUSTOMER HAS REQUESTED AN EVAL OF THE PART TO DETERMINE IF IT COULD HAVE ATTRIBUTED TO THE DELAY IN SURGERY. THE INVESTIGATION IS IN PROCESS AND ONCE COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A FORM WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENT REPORT NUMBER SHOULD HAVE BEEN MARKED AS FOLLOW-UP 001 BUT IT WAS INADVERTENTLY NUMBERED AS FOLLOW-UP 002 AND SUBMITTED IN ERROR. DATE OF FDA REQUEST AND VIANT MEDICAL AWARENESS OF ERROR.

    Additional Manufacturer Narrative · 1

    GREATBATCH MEDICAL IS NOT THE LEGAL MANUFACTURER OF THE DEVICE INVOLVED IN THIS INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA EMAIL ON (B)(6) 2013; ROUTINE ACETABULAR PREPARATION FOR TRIDENT HEMISPHERICAL SOLID BACKED SHELL USING HIP 1.4 NAVIGATION ON (B)(6) FEMALE. UNDER REAMED BY 1MM. (REAMED 51MM TO IMPLANT 52MM SHELL) WHEN IMPACTING THE SOLID BACKED 52MM SHELL, SURGEON SAID THEY HAD SOME INITIAL FIXATION, HOWEVER, WHEN SURGEON TRIED TO FULLY SEAT THE SHELL, FIXATION WAS LOST AND THE SHELL WOULD NOT GRIP. SURGEON REMOVED THE SHELL AND RE REAMED WITH THE 51MM REAMER (GREATBATCH PART 2102-0451, LOT V34647001) TO DEEPEN THE ACETABULUM. THE SURGEON THEN REINSERTED THE 52MM SOLID BACKED TRIDENT SHELL AND AGAIN THE SHELL WOULD NOT GRIP. SURGEON DECIDED TO UTILIZE A 52MM TRIDENT HEMISPHERICAL CLUSTER SHELL. THE SURGEON HAD DIFFICULTY WITH FIXATION WITH THIS SHELL TOO AND 3 SCREWS WERE REQUIRED TO GIVE SOME INITIAL STABILITY. SURGEON HAS REQUESTED EVAL OF THE SHELL AS WELL AS THE 51MM REAMER (GREATBATCH PART 2102-0451, LOT V34647001). PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, ADD'L SURGICAL TIME WAS REQUIRED TO IMPLANT SECOND ACETABULAR COMPONENT WITH SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350500 ACETABULAR REAMER 51MM ACETABULAR REAMER 51MM HWE GREATBATCH MEDICAL, INC. 2102-0451 V34647001

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention