BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL HUMERUS PROXIMAL ULNA

    MDR report key: 23321578 · Received October 17, 2025

    Report

    Report Number
    0002249697-2025-01113
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 18, 2025
    Report Date
    February 25, 2026
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING LOOSENING INVOLVING A PATIENT SPECIFIC, HEMI PELVIS, OTHER (PELVIC IMPLANT) WAS REPORTED. THE EVENT WAS CONFIRMED VIA CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS. 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: "CONFIRMATION OF EVENT: I CAN CONFIRM THAT THE PATIENT UNDERWENT A CUSTOM HEMI PELVIS TYPE TUMOR PROSTHESIS SINCE I WAS ABLE TO REVIEW AN X-RAY WITH THE LOOSENED IMPLANT IN PLACE. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. CAUSES OF LOOSENING OF A MEGA TUMOR TYPE PROSTHESIS ARE MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE, AND PATIENT ACTIVITY LEVEL, LIFESTYLE AND BMI. WITH THE INFORMATION PROVIDED I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANTED ITSELF. IT WOULD NOT BE UNUSUAL FOR A SALVAGE IMPLANT SUCH AS THIS TO LOOSEN OVERTIME. PATIENT WAS ABLE TO FUNCTION APPARENTLY FOR OVER 11 YEARS WHICH IS IN MY OPINION A SATISFACTORY INITIAL RESULT." -PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE REPORTED DEVICE WAS MANUFACTURED WITH NO REPORTED RELEVANT DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT IS PLANNED TO BE REVISED DUE TO LOOSENING OF THE HEMI PELVIS. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: "CONFIRMATION OF EVENT: I CAN CONFIRM THAT THE PATIENT UNDERWENT A CUSTOM HEMI PELVIS TYPE TUMOR PROSTHESIS SINCE I WAS ABLE TO REVIEW AN X-RAY WITH THE LOOSENED IMPLANT IN PLACE. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. CAUSES OF LOOSENING OF A MEGA TUMOR TYPE PROSTHESIS ARE MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE, AND PATIENT ACTIVITY LEVEL, LIFESTYLE AND BMI. WITH THE INFORMATION PROVIDED I WOULD NOT ASSIGN ANY CAUSALITY TO THE IMPLANTED ITSELF. IT WOULD NOT BE UNUSUAL FOR A SALVAGE IMPLANT SUCH AS THIS TO LOOSEN OVERTIME. PATIENT WAS ABLE TO FUNCTION APPARENTLY FOR OVER 11 YEARS WHICH IS IN MY OPINION A SATISFACTORY INITIAL RESULT." 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.

    Additional Manufacturer Narrative · 0

    CUSTOM DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO SIMILAR EVENTS FOR THE LOT REFERENCED. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED: "THIS LADY SUFFERED FROM PELVIC CHONDROSARCOMA WITH INDEX TUMOR RESECTION & CUSTOM ENDOPROSTHETIC RECONSTRUCTION. THE ENDOPROSTHESIS HAS LOOSENED AND WE WOULD LIKE TO PLAN FOR REVISION." LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2819923 TOTAL HUMERUS PROXIMAL ULNA PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH PIN 18620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other