BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII PLASTIC REAMTHRU FEM TRL SZ 6 RT

    MDR report key: 8190287 · Received December 21, 2018

    Report

    Report Number
    1020279-2018-02869
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 4, 2018
    Report Date
    March 1, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556625873
    PMA / PMN Number
    K142807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE FOR COMPLAINT C-0223190 WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE WAS FRACTURED ON BOTH CONDYLES NEXT TO THE THREADED INSERTS. THE DEVICE WAS MANUFACTURED IN 2017 AND EXHIBITS SIGNS OF MODERATE WEAR/USAGE. THE DEVICE ON COMPLAINT C-0223204 WAS NOT RETURNED FOR EVALUATION. A REVIEW OF COMPLAINT HISTORY FOR BOTH DEVICES DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. A REVIEW OF THE MANUFACTURING RECORDS FOR BOTH DEVICES DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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 COMPLAINTS WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THESE COMPLAINTS; 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 THE PLASTIC TRIAL BROKE WHEN IMPACTED. NO DELAY, INJURY OR BACK UP REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE PLASTIC TRIAL BROKE WHEN IMPACTED. NO DELAY, INJURY OR BACK UP REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030343 GII PLASTIC REAMTHRU FEM TRL SZ 6 RT PROSTHESS, KNE,PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, PLYMER/METAL JWH SMITH & NEPHEW, INC. 17LB00414 00885556625873

    Patients

    Seq Age Sex Outcome Treatment
    1