BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII PS HI FLEX ISRT SZ 3-4 13

    MDR report key: 18950026 · Received March 21, 2024

    Report

    Report Number
    1020279-2024-00578
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 20, 2024
    Report Date
    April 9, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010492920
    PMA / PMN Number
    K032295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: REPORTS 1020279-2024-00548 AND 1020279-2024-00578 OCCURRED DURING THE SAME SURGERY. EVENT WAS COMPLETED USING THIRD S+N INSERT BACK-UP DEVICE.

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). H10: SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 C.F.R. PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION REVEALED SCRATCHES AND GOUGES IN THE SURFACE OF THE DEVICE. THE VISUAL ALSO REVEALS THE DEVICE HAS DAMAGE ALONG THE BASE, MORE THAN LIKELY FROM ATTEMPTED INSERTION. THIS INSPECTION WAS CONDUCTED USING A MAGNIFYING GLASS. A DIMENSIONAL EVALUATION PERFORMED ON THE DEVICE REVEALED THAT THE DEVICE HAS DAMAGE THAT APPEARS TO BE FROM ATTEMPTED USE AND HAS THE POTENTIAL TO CAUSE AN EVENT DURING ATTEMPTED MATING TO THE TIBIAL BASE AS DESCRIBED IN THE COMPLAINT. THE DAMAGE/DEFORMATION OF SEVERAL FEATURES WOULD NOT ALLOW FOR ACCURATE MEASUREMENT. ALL MEASURABLE CRITICAL FEATURES THAT COULD BE MEASURED WERE WITHIN SPECIFICATION. THE DIMENSIONAL INSPECTION OF THE RETURNED DEVICE DID NOT INDICATE THE PRODUCT WAS DEFECTIVE AT THE TIME OF SHIPMENT FROM THE MANUFACTURING SITE. THESE DEVICES ARE SUBJECTED TO MULTIPLE VISUAL AND DIMENSIONAL INSPECTION DURING PROCESSING, AND THIS TYPE OF DAMAGE HAS A HIGH LIKELIHOOD OF DETECTION DURING THESE INSPECTIONS. BASED ON THE INFORMATION PROVIDED, THE UNSATISFACTORY EXPERIENCE COULD BE CONFIRMED. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY REVEALED A SIMILAR EVENT FOR THE LISTED DEVICE OVER THE PREVIOUS 12 MONTHS, BUT NO SIMILAR EVENTS FOR THE BATCH BASED ON THE HISTORICAL DATA, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE SIZE SELECTED OR INSERTION TECHNIQUE. 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. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII PS HI FLEX ISRT SZ 3-4 13 (BACK-UP) WOULD NOT SEAT INTO TIBIA TRAY AFTER MULTIPLE ATTEMPTS. A A BACK-UP INSERT WAS OPENED AND FINALLY SEATED. SURGEON HAS HAD MULTIPLE INSTANCES OF THIS OCCURRING WITH PS HIGH FLEXION INSERTS, AND IS DIS-SATISFIED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926491 GII PS HI FLEX ISRT SZ 3-4 13 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 23HM05884 03596010492920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown