BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RDCE FRCPS W/ PTS BRD

    MDR report key: 10197504 · Received June 25, 2020

    Report

    Report Number
    1020279-2020-02752
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    June 3, 2020
    Report Date
    March 15, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDG
    PMA / PMN Number
    K123598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. THE VISUAL INSPECTION OF THE RETURNED FORCEP CONFIRMS THE TIP IS BENT. THIS DEVICE WAS MANUFACTURED IN 2019. THIS DEVICE SHOWS SIGNS OF SIGNIFICANT WEAR AND USAGE. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; 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. THIS DEVICE IS A REUSABLE INSTRUMENTS THAT CAN BE EXPOSED TO NUMEROUS SURGERIES; DAMAGE FROM REPEATED USE CAN OCCUR. EXPECTED WEAR/TEAR IS LIKELY THE PROBABLE CAUSE OF THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINTS WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THESE COMPLAINTS; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PROCEDURE, DURING AN E FIP INSPECTION IT WAS FOUND THAT THE TIP OF THE RDCE FRCPS W/ PTS BRD WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658369 RDCE FRCPS W/ PTS BRD PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW, INC. 19LTCD153

    Patients

    Seq Age Sex Outcome Treatment
    1