BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPLANT IMPACTOR

    MDR report key: 18133710 · Received November 14, 2023

    Report

    Report Number
    1020279-2023-02229
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 24, 2023
    Report Date
    December 12, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDG
    UDI-DI
    00885556034156
    PMA / PMN Number
    K123598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALS ONE OF THE CAM ARM COVERS BROKE INTO TWO PIECES. BOTH PIECES WERE RETURNED. THE DEVICE SHOWS SIGNS OF SIGNIFICANT WEAR AND USE. A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE LISTED DEVICE OVER THE PREVIOUS 12 MONTHS, BUT NO SIMILAR EVENTS FOR THE BATCH BASED ON THE HISTORICAL DATA, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE DO NOT HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THIS EVENT WAS PREVIOUSLY IDENTIFIED AND ADDRESSED; A STRESS RELIEF PROCESS WAS ESTABLISHED FOR ACETAL BUMPERS, SAMPLES WERE TESTED IN ORDER TO INCLUDE THE STRESS RELIEF OPERATION IN THE MANUFACTURING FLOW AND TO INCLUDE THE INSPECTION OF STRESS RELIEF TEMPERATURE CHART TO DETERMINE COMPLIANCE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY POTENTIAL FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TKA SURGERY, IN A FEMORAL IMPLANT IMPACTOR, THE PLASTIC LOCKING PIECE BROKE OFF OF THE MAIN FRAME OF THE IMPACTOR. NO PIECES FELL INSIDE THE PATIENT. THE IMPACTOR AND BROKEN PIECES ARE ALL RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619865 FEMORAL IMPLANT IMPACTOR PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW, INC. 18LM14238 00885556034156

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown