BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGION 4 IN 1 BLOCK SIZE 6 WIDE

    MDR report key: 11311964 · Received February 10, 2021

    Report

    Report Number
    1020279-2021-01109
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 19, 2021
    Report Date
    April 14, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRY
    UDI-DI
    00885556772225
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE, USED IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMS THE STATED FAILURE MODE. THE DEVICE HAS AN ALIGNMENT PIN AT THE BACK SIDE THAT IS BROKE OFF, RENDERING THE DEVICE INOPERABLE. THE DEVICE WAS MANUFACTURED IN 2019 AND SHOWS SIGNS OF EXTENSIVE USE. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE DO NOT HAVE 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. SHOULD 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. CASE-2021-00037981-1

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEG OF A CUSTOM GEN 2 SZ 6 CUTBLOCK BROKE OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206006 LEGION 4 IN 1 BLOCK SIZE 6 WIDE PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY SMITH & NEPHEW, INC. 19MM09898 00885556772225

    Patients

    Seq Age Sex Outcome Treatment
    1