BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

    MDR report key: 4955724 · Received July 31, 2015

    Report

    Report Number
    3004105610-2015-00068
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. REGARDING SIZE SMALL AXLES, THE SURGICAL TECHNIQUE (SECTION 2) PROVIDES CLEAR INSTRUCTIONS REGARDING THE USE OF THE CIRCLIP WHICH WAS PROVIDED, AND NOT AN END CAP, AS REPORTED BY THE USER. NOTE THAT SIZE EXTRA SMALL AXLES DOES REQUIRE THE USE OF THE END CAP. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE SURGEON REGARDING THE REPORTED EVENT, THE SURGEON'S COMMENTS REGARDING THE TIBIAL PLATEAU SIZING, AND THE INSTRUMENTS THAT THE SURGEON WOULD PREFER BE INCLUDED WITH THE DEVICE. AFTER NOT RECEIVING ANY RESPONSE TO THE COMPANY'S REQUEST FOR THIS ADDITIONAL INFORMATION, A SECOND REQUEST HAS BEEN FORWARDED TO THE SURGEON. A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152). IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE SURGEON REPORTED TO THE DISTRIBUTOR THAT THE IMPLANT SIZING WAS OPTIMAL. HOWEVER, HE STATED THAT THE "TIBIAL PLATEAU WAS SLIGHTLY SMALL, BUT THAT THIS WAS A NECESSARY COMPROMISE WITH THE OPTIONS AVAILABLE" INVOLVING A DISTAL FEMUR JTS. THE SURGEON DID NOT REQUEST A SPECIFIC SIZE PLATEAU PLATE. THE CUSTOM IMPLANT WAS APPROVED BY THE SURGEON BEFORE SHIPMENT AND THE STANDARD PLATEAU PLATE SELECTION SUPPLIED WITH THIS KIT WERE SUFFICIENT FOR THE SURGEON TO COMPLETE THE PROCEDURE. (B)(4): THE SURGEON REPORTED THAT HE BELIEVED ADDITIONAL INSTRUMENTS SHOULD HAVE BEEN PROVIDED WITH THE DISTAL FEMUR JTS, HOWEVER HE WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE INSTRUMENTS AVAILABLE IN THE OPERATING ROOM. THE STANDARD INSTRUMENT SET SUPPLIED WITH THIS KIT WERE SUFFICIENT FOR THE SURGEON TO COMPLETE THE PROCEDURE. (B)(4): THE SURGEON REPORTED THAT A CAP FOR THE AXLE WAS NOT PROVIDED FOR THE DISTAL FEMUR JTS THE IMPLANT SUPPLIED WAS SIZE SMALL, ONLY SIZE EXTRA SMALL IMPLANTS REQUIRE AN AXLE CAP. THE SURGICAL TECHNIQUE (SECTION 2) PROVIDES CLEAR INSTRUCTIONS REGARDING THE USE OF THE CIRCLIP WHICH WAS PROVIDED, AND NOT AN END CAP, AS REPORTED BY THE USER. CIRCLIPS WERE CORRECTLY PROVIDED WITH THIS IMPLANT. END CAPS WERE NOT PROVIDED AS THEY ARE INCORRECT FOR THIS SIZE IMPLANT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. REQUESTS WERE MADE FOR FURTHER INFORMATION IN RELATION TO THIS INCIDENT HOWEVER THE REQUESTED INFORMATION WAS NOT PROVIDED TO STANMORE IMPLANTS WORLDWIDE (SIW). FURTHER INFORMATION SUCH AS PRODUCT DETAILS, PRODUCT RETURN, PRE- AND POST-OPERATIVE X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. SIW WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE DISTRIBUTOR THAT THE IMPLANT SIZING WAS OPTIMAL. HOWEVER, HE STATED THAT ALTHOUGH THE "TIBIAL PLATEAU WAS SLIGHTLY SMALL, BUT THAT THIS WAS A NECESSARY COMPROMISE WITH THE OPTIONS AVAILABLE". THE SURGEON ALSO REPORTED THAT HE BELIEVED ADDITIONAL INSTRUMENTS SHOULD HAVE BEEN PROVIDED WITH THE DEVICE, HOWEVER HE WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE INSTRUMENTS AVAILABLE IN THE OPERATING ROOM. THE SURGEON FURTHER REPORTED THAT A CAP FOR THE AXLE WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE DISTRIBUTOR THAT THE IMPLANT SIZING WAS OPTIMAL. HOWEVER, HE STATED THAT ALTHOUGH THE "TIBIAL PLATEAU WAS SLIGHTLY SMALL, BUT THAT THIS WAS A NECESSARY COMPROMISE WITH THE OPTIONS AVAILABLE." THE SURGEON ALSO REPORTED THAT HE BELIEVED ADDITIONAL INSTRUMENTS SHOULD HAVE BEEN PROVIDED WITH THE DEVICE, HOWEVER HE WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE INSTRUMENTS AVAILABLE IN THE OPERATING ROOM. THE SURGEON FURTHER REPORTED THAT A CAP FOR THE AXLE WAS NOT PROVIDED. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00068 (B)(4). THIS COMPLAINT HAS BEEN SPLIT INTO 3 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501632 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 19453 PIN 19453

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other