BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS II SPC F/E SZ GDE

    MDR report key: 8452269 · Received March 26, 2019

    Report

    Report Number
    1020279-2019-01181
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 4, 2019
    Report Date
    June 26, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBH
    UDI-DI
    00885556059951
    PMA / PMN Number
    K121393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED GENESIS II SPC FLEXION/EXTENSION GAP BALANCING SIZING GUIDE INDICATED THAT A LASER MARK IS MISSING, CONFIRMING THE STATED COMPLAINT. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PART DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH; HENCE WE CONSIDER THIS AN ISOLATED EVENT. 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. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED GENESIS II SPC FLEXION/EXTENSION GAP BALANCING SIZING GUIDE INDICATED THAT ALL LASER ETCHING WAS PRESENT TO PRINT. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PART DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE BALANCE MEASUREMENT TOOL OF THE KNEE JOINT DID NO MARK THE LINE, AND IT CANNOT CORRECTLY MARK THE OSTEOTOMY. THERE WAS NOT AN S&N BACKUP DEVICE AVAILABLE AND THE SURGEON HAD TO USE REGULAR TOOLS INSTEAD AND DIVERT FROM THE ORIGINAL PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245185 GENESIS II SPC F/E SZ GDE PROSTH, KNEE, PATE/FEMOROTIBIAL, SUNCEM, PORO, COAT, POLY/METAL/POLY MBH SMITH & NEPHEW, INC. 16KCT0009 00885556059951

    Patients

    Seq Age Sex Outcome Treatment
    1