BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII MIS DCF ALIGN GDE

    MDR report key: 10293461 · Received July 18, 2020

    Report

    Report Number
    1020279-2020-03334
    Event Type
    Malfunction
    Date Received
    July 18, 2020
    Date of Event
    June 25, 2020
    Report Date
    December 8, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRY
    UDI-DI
    03596010497161
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE, USED IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE DEVICE SHOWS SIGNIFICANT SIGNS OF WEAR/USAGE. A FUNCTIONAL EVALUATION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE WAS PAIRED WITH A MATING DEVICE AND THE LOCKING MECHANISM CEASED. THE DEVICE WAS MANUFACTURED IN 2015 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING E FIP INSPECTION, IT WAS NOTICED THAT THIS DEVICE WILL NOT LOCK. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757250 GII MIS DCF ALIGN GDE PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY SMITH & NEPHEW, INC. 71441144 15MM07208 03596010497161

    Patients

    Seq Age Sex Outcome Treatment
    1