BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI TRIAL FEM HEAD 32 +0

    MDR report key: 11683506 · Received April 18, 2021

    Report

    Report Number
    1020279-2021-03077
    Event Type
    Malfunction
    Date Received
    April 18, 2021
    Date of Event
    March 23, 2021
    Report Date
    May 27, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    UDI-DI
    03596010555618
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE PRODUCT ANALYSIS AND THE REPORTED EVENT COULD NOT BE CONFIRMED AT THIS TIME. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. 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. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED. H8

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THREE 32 +0 TRIAL HEADS ARE WORN AND WILL NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580995 MI TRIAL FEM HEAD 32 +0 PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC. 71369715 UNKNOWN 03596010555618

    Patients

    Seq Age Sex Outcome Treatment
    1