BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURAT LS INSERT LRG 15MM

    MDR report key: 23334762 · Received October 20, 2025

    Report

    Report Number
    0002249697-2025-01137
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    November 16, 2023
    Report Date
    December 18, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    UDI-DI
    07613327046984
    PMA / PMN Number
    K921640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING WEAR INVOLVING A KINEMAX INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: 'I CAN CONFIRM THAT THE PATIENT UNDERWENT A RIGHT KINEMAX PLUS TOTAL KNEE ARTHROPLASTY SINCE I WAS ABLE TO SEE AN X-RAY WITH THE IMPLANT IN PLACE. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. THE CAUSES OF POLYETHYLENE WEAR AT 24 YEARS AFTER IMPLANTATION ARE MULTIFACTORIAL. THESE CAUSES INCLUDE SURGICAL TECHNIQUE IN THE WAY THE IMPLANT IS POSITIONED AND BALANCED WITH PROPER RESTORATION OF THE KINEMATICS OF THE KNEE. OTHER CONTRIBUTING CAUSES INCLUDE PATIENT FACTORS SUCH AS THE PATIENT'S ACTIVITY LEVEL, LIFESTYLE AND BMI. WHILE POLYETHYLENE WEAR IS AN IMPLANT ISSUE, I COULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT UNLESS IT COULD BE SHOWN THAT THERE WAS SOME DEFECT IN THE MANUFACTURING PROCESS. WEAR OF THE POLYETHYLENE COMPONENT CAN BE ATTRIBUTED TO DEVELOPMENT OF LIGAMENTOUS LAXITY WITH ALTERATION OF KNEE KINEMATICS, THEREBY PUTTING UNDO STRESS ON THE INSERT.' -PRODUCT HISTORY REVIEW: PRODUCT HISTORY REVIEW COULD NOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT 'AT PRESENT, THE PATIENT HAS WORN OUT HIS POLYETHYLENE LINER, RESULTING IN MCL ATTENUATION AND ANTEROMEDIAL SUBLUXATION, AND AN EXTREMELY UNSTABLE KNEE. PLASTIC SURGERY HAS EVALUATED THE PATIENT DUE TO HIS POOR WOUND HEALING POTENTIAL, AND BELIEVE HE HAS AN EXTREMELY HIGH CHANCE OF A WOUND HEALING COMPLICATION WITH ANY SURGICAL INSULT. TO REDUCE THE LIKELIHOOD OF A COMPLICATION, I'D LIKE TO PERFORM A POLYETHYLENE LINER EXCHANGE, AS OPPOSED TO A COMPLETE REVISION, IF POSSIBLE. THE LINER EXCHANGE WOULD PROVIDE KNEE STABILITY WITHOUT THE SOFT TISSUE AND BONY TRAUMA FROM AN EXTENSIVE, FULL COMPONENT REVISION, AND REDUCE THE LIKELIHOOD OF A COMPLICATION.' A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED THE FOLLOWING: 'I CAN CONFIRM THAT THE PATIENT UNDERWENT A RIGHT KINEMAX PLUS TOTAL KNEE ARTHROPLASTY SINCE I WAS ABLE TO SEE AN X-RAY WITH THE IMPLANT IN PLACE. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. THE CAUSES OF POLYETHYLENE WEAR AT 24 YEARS AFTER IMPLANTATION ARE MULTIFACTORIAL. THESE CAUSES INCLUDE SURGICAL TECHNIQUE IN THE WAY THE IMPLANT IS POSITIONED AND BALANCED WITH PROPER RESTORATION OF THE KINEMATICS OF THE KNEE. OTHER CONTRIBUTING CAUSES INCLUDE PATIENT FACTORS SUCH AS THE PATIENT'S ACTIVITY LEVEL, LIFESTYLE AND BMI. WHILE POLYETHYLENE WEAR IS AN IMPLANT ISSUE, I COULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANT UNLESS IT COULD BE SHOWN THAT THERE WAS SOME DEFECT IN THE MANUFACTURING PROCESS. WEAR OF THE POLYETHYLENE COMPONENT CAN BE ATTRIBUTED TO DEVELOPMENT OF LIGAMENTOUS LAXITY WITH ALTERATION OF KNEE KINEMATICS, THEREBY PUTTING UNDO STRESS ON THE INSERT.' NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED: AS PER PSS IMPLANT REQUEST: 73 YO MALE W/ PMH NOTABLE FOR PERIPHERAL VASCULAR DISEASE C/B EXTREMELY POOR WOUND HEALING POTENTIAL AND AFIB (S/P PERMANENT PACEMAKER, ON ELIQUIS). UNDERWENT RIGHT DISTAL FEMORAL OSTEOTOMY PROCEDURE IN ~1964, AND SUBSEQUENTLY RIGHT DISTAL FEMUR REMOVAL OF HARDWARE, TKA IN 2001 (KINEMAX PLUS EXTRA-LARGE FEMUR, LARGE TIBIA, LARGE PATELLA, 15MM POLYETHYLENE LINER). AT PRESENT, THE PATIENT HAS WORN OUT HIS POLYETHYLENE LINER, RESULTING IN MCL ATTENUATION AND ANTEROMEDIAL SUBLUXATION, AND AN EXTREMELY UNSTABLE KNEE. PLASTIC SURGERY HAS EVALUATED THE PATIENT DUE TO HIS POOR WOUND HEALING POTENTIAL AND BELIEVE HE HAS AN EXTREMELY HIGH CHANCE OF A WOUND HEALING COMPLICATION WITH ANY SURGICAL INSULT. TO REDUCE THE LIKELIHOOD OF A COMPLICATION, I'D LIKE TO PERFORM A POLYETHYLENE LINER EXCHANGE, AS OPPOSED TO A COMPLETE REVISION, IF POSSIBLE. THE LINER EXCHANGE WOULD PROVIDE KNEE STABILITY WITHOUT THE SOFT TISSUE AND BONY TRAUMA FROM AN EXTENSIVE, FULL COMPONENT REVISION, AND REDUCE THE LIKELIHOOD OF A COMPLICATION. UPDATE 06-OCTOBER-2025 (B)(6): SPOKE TO REP. THE SURGEON DECIDED NOT TO GO WITH A CUSTOM IMPLANT FOR THIS PATIENT. THE REP IS NOT AWARE IF THE PATIENT WAS REVISED WITH OFF-THE-SHELF COMPONENTS OR ANY COMPETITOR DEVICES. THE REP IS UNABLE TO OBTAIN ANY FURTHER INFORMATION FROM THE HOSPITAL OR SURGEON.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2860238 KX+ DURAT LS INSERT LRG 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH 8VMT / 9817399 07613327046984

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H