BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R3 LINER IMPACTOR HEAD 32MM

    MDR report key: 12038829 · Received June 22, 2021

    Report

    Report Number
    1020279-2021-05271
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 3, 2021
    Report Date
    August 3, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    UDI-DI
    03596010599971
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES FOR THE LISTED DEVICE; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. 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. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS 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 AN R3 LINER IMPACTOR HEAD IS CRACKED. IT IS UNKNOWN WHETHER THIS PROBLEM HAPPENED DURING SURGERY; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934992 R3 LINER IMPACTOR HEAD 32MM PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC. UNK 03596010599971

    Patients

    Seq Age Sex Outcome Treatment
    1