BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI TRIAL FEM HEAD 32 +0

    MDR report key: 11780690 · Received May 5, 2021

    Report

    Report Number
    1020279-2021-03765
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 9, 2021
    Report Date
    July 13, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    UDI-DI
    07611996121834
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; 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 DURING SURGERY, WHILE THE TRIAL FEMORAL HEAD 32 S/+0 WAS INSIDE THE PATIENT, THE SURGEON NOTICED THAT DEVICE WAS WORN OUT, AND THE PLASTIC HAD FLEXED TO THE POINT THAT THE TRIAL NO LONGER GRIPPED ONTO THE TRIAL NECK SUFFICIENTLY. PROCEDURE CONTINUED WITH THE SAME DEVICE, WITHOUT A SURGICAL DELAY OR AN INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677994 MI TRIAL FEM HEAD 32 +0 PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC. 75100850 UNK 07611996121834

    Patients

    Seq Age Sex Outcome Treatment
    1