BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUL FEM IMPACTOR HEAD LOCKING

    MDR report key: 12287903 · Received August 6, 2021

    Report

    Report Number
    1038671-2021-00373
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 16, 2021
    Report Date
    November 22, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862523587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WERE NO PARTS OR PIECES OF THE DEVICE THAT FELLED INTO THE PATIENT. (H3) THE BROKEN DEVICE REPORTED WAS LIKELY THE RESULT OF THE FEMORAL IMPACTOR HEAD BEING DIRECTLY IMPACTED DURING THIS SURGERY OR A PREVIOUS SURGICAL USE, WHICH MAY HAVE IMPOSED HIGH LOADS TO THE THREADED SHAFT AND LED TO CRACK INITIATION, PROPAGATION, AND ULTIMATE FRACTURE OF THE THREADED SHAFT. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "BROKEN / NON-FUNCTIONAL" IS ASSOCIATED WITH A PARTIAL OR FULL-THICKNESS CRACK IN THE DEVICE MATERIALS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1038671-2021-00372 AND 1038671-2021-00373.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1038671-2021-00372 AND 1038671-2021-00373.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1038671-2021-00372.

    Description of Event or Problem · 1

    AS REPORTED, THE PIN PULLER (CAT# 02-029-90-4100) WAS USED TO REMOVE THE PINS OUT OF THE TIBIA. THE BONE QUALITY WAS VERY GOOD AND WHEN THE SURGEON TRIED TO REMOVE THE PIN, THE TIP OF THE PIN PULLER BROKE OFF. FURTHERMORE, THE FEM IMPACTOR (02-029-19-1000) WAS BROKEN ON IMPACTION WHEN WE WERE IMPACTING THE FINAL FEMUR IMPLANT ON. ONE OF THE SIDES OF THE IMPACTOR BROKE OFF. THE SURGERY WAS NOT AFFECTED BY THE BREAKAGE. WE HAD BACKUPS AND THE CASE WENT VERY WELL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188510 TRUL FEM IMPACTOR HEAD LOCKING PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRUL FEM IMPACTOR HEAD LOCKING UNK 10885862523587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown