BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KMAX STEM EXTNR(S,M,L,XL),80MM

    MDR report key: 4221686 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04126
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K904208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INTRA-OPERATIVE MALALIGNMENT INVOLVING A KINEMAX STEM EXTENDER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: BASED ON A PROVIDED PHOTOGRAPH, THERE APPEARS TO BE A SLIGHTLY UNEVEN GAP AT THE STEM - TIBIAL BOSS JUNCTION, WHICH COULD BE AN INDICATION OF CROSS-THREADING BETWEEN THE EXTERNAL STEM THREAD AND THE INTERNAL BOSS THREAD DURING ASSEMBLY IN THE OR. NO FURTHER MATERIAL ANALYSIS WAS POSSIBLE AS THE TIBIAL CONSTRUCT WAS SUBSEQUENTLY IMPLANTED AS NO ALTERNATIVE PRODUCT WAS AVAILABLE. MEDICAL RECORDS RECEIVED AND EVALUATION: THE MEDICAL REVIEW INDICATED THAT ALTHOUGH THE EXACT CAUSE OF THE UNEQUAL TIBIAL CONNECTOR GAP SPACE REMAINS OBSCURE AS LONG AS THEY REMAIN TO BE IMPLANTED, THE MOST PROBABLE EXPLANATION FOR FAILURE OF THIS EVENT WOULD BE PROCEDURE-RELATED AS CAUSED BY POTENTIAL CROSS-THREADING OF THE DEVICES. IF FAILURE MIGHT DEVELOP, STILL NOT VERY PROBABLE UNDER THE CURRENT IMPLANTATION CONDITIONS, EXPLANT MATERIALS ANALYSIS MIGHT PROVIDE THE ULTIMATE ANSWER WHETHER CROSS-THREADING WAS THE UNDERLYING PROBLEM OR SOMETHING ELSE. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: ALTHOUGH THERE APPEARS TO BE A SLIGHT MALALIGNMENT BETWEEN THE TIBIAL STEM EXTENDER AND ITS MATING TIBIAL BASEPLATE BASED ON THE PHOTOGRAPH PROVIDED, AN EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE TIBIAL CONSTRUCT WAS NOT RETURNED FOR ANALYSIS AS IT WAS IMPLANTED. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT WHEN HE IMPLANTED AN MRH TIBIA WITH A GMRS DISTAL FEMUR IN A (B)(6) YEAR OLD MALE PATIENT UNDERGOING A RIGHT KNEE REVISION, HE NOTICED ON EXAMINATION OF THE MEDIUM BASEPLATE (6481-3-102) AND THE 80MM CEMENTED STEM JUNCTION (6476-8-260) THAT THERE WAS ALLEGEDLY AN INCOMPLETE JOIN AND THAT THE DISTAL PORTION OF THE BOSS OF THE BASEPLATE LOOKED ANGULAR RATHER THAN AT 90 DEGREES.

    Description of Event or Problem · 1

    THIS DEVICE WAS IMPLANTED DURING A 3RD REVISION (SECOND STRYKER REVISION). ACTIVITY LEVEL - NORMAL FOR AGE, NO SPECIFIC EVENTS OR TRAUMA REPORTED IN THE LEAD UP TO THIS REVISION. THE CUSTOMER HAS REPORTED THAT THE SCORPIO TS PROCEDURE DID NOT HAPPEN AND THAT THE PFC WAS REPLACED BY AN MRH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703172 KMAX STEM EXTNR(S,M,L,XL),80MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH EH7YB

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other