BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R3 OFFSET IMPACTOR

    MDR report key: 10258422 · Received July 10, 2020

    Report

    Report Number
    1020279-2020-03050
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    June 17, 2020
    Report Date
    June 8, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    PMA / PMN Number
    K123598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED AT THIS TIME. SO THE REPORTED EVENT COULD NOT BE CONFIRMED. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PART REVEALED PRIOR COMPLAINTS FOR THE LISTED BATCH WITH THE SAME FAILURE MODE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES; DAMAGE FROM REPEATED USE CAN OCCUR. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY PROBABLE CAUSES 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 COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION WARRANTED FOR THIS COMPLAINT; 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 DURING THR PROCEDURE THE SHAFT OF TEAR DROP MECHANISM CRACKED WHILE IMPACTING. THE DEVICE CRACK OUTSIDE THE PATIENT. NOTHING FELL INTO PATIENT. NO DELAY. THE PROCEDURE WAS FINISHED USING A S+N BACKUP DEVICE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723532 R3 OFFSET IMPACTOR PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1