BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIATHLON #4 CS ALLPOLY 9MM

    MDR report key: 23617278 · Received November 21, 2025

    Report

    Report Number
    0002249697-2025-01368
    Event Type
    Death
    Date Received
    November 21, 2025
    Date of Event
    May 30, 2023
    Report Date
    March 25, 2026
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327043259
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS 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 WITH A CLINICAL CONSULTANT INDICATED "CONFIRMATION OF EVENT: I CAN CONFIRM THAT THE PATIENT HAD THE PRIMARY KNEE REPLACEMENT, THE INCISION AND DRAINAGE AND IRRIGATION AND DEBRIDEMENT, AS WELL AS THE RE-IMPLANTATION PROCEDURE SINCE I WAS ABLE TO REVIEW OPERATION REPORTS AND MEDICAL RECORDS. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THESE EVENTS CANNOT BE DETERMINED WITH CERTAINTY. THE CAUSES OF POSTOPERATIVE JOINT INFECTION ARE MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE, OPERATING ROOM ENVIRONMENT, PATIENT FACTORS INCLUDING THE PATIENT'S OWN MICROBIOME AND THE PATIENT'S GENERAL HEALTH. SPREAD FROM A REMOTE SITE WITH BACTERIA CAN OCCUR AND CAUSE A PERIPROSTHETIC INFECTION. THIS PATIENT WAS MORBIDLY OBESE WHICH ALSO CONTRIBUTES TO AN INCREASED RISK OF INFECTION. AS TO THE CARDIAC ARRHYTHMIA, THIS IS A MEDICAL CONDITION THAT ONCE IT HAPPENS, AT TIMES IT IS NOT CORRECTABLE AND THE PATIENT DOES NOT SURVIVE, AS WITH WHAT HAPPENED IN THIS CASE. I WOULD NOT ASSIGN ANY CAUSALITY OF THESE EVENTS TO THE IMPLANT ITSELF. 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 1 OTHER SIMILAR EVENTS FOR THE LOT AND STERILE LOT REFERENCED HOWEVER IT RELATES TO THE SAME DEVICE AND PATIENT. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ALL STRYKER PRODUCTS ARE SOLD AS STERILE EITHER BY BEING VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL SAL OF 10^-6 OR ASEPTICALLY FILLED UNDER A VALIDATED PROCESS IN ACCORDANCE WITH APPLICABLE EXTERNAL STANDARDS. A REVIEW WITH A CLINICAL CONSULTANT INDICATED "CONFIRMATION OF EVENT: I CAN CONFIRM THAT THE PATIENT HAD THE PRIMARY KNEE REPLACEMENT, THE INCISION AND DRAINAGE AND IRRIGATION AND DEBRIDEMENT, AS WELL AS THE RE-IMPLANTATION PROCEDURE SINCE I WAS ABLE TO REVIEW OPERATION REPORTS AND MEDICAL RECORDS ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THESE EVENTS CANNOT BE DETERMINED WITH CERTAINTY. THE CAUSES OF POSTOPERATIVE JOINT INFECTION ARE MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE, OPERATING ROOM ENVIRONMENT, PATIENT FACTORS INCLUDING THE PATIENT'S OWN MICROBIOME AND THE PATIENTS GENERAL HEALTH. SPREAD FROM A REMOTE SITE WITH BACTERIA CAN OCCUR AND CAUSE A PERIPROSTHETIC INFECTION. THIS PATIENT WAS MORBIDLY OBESE WHICH ALSO CONTRIBUTES TO AN INCREASED RISK OF INFECTION. AS TO THE CARDIAC ARRHYTHMIA, THIS IS A MEDICAL CONDITION THAT ONCE IT HAPPENS, AT TIMES IT IS NOT CORRECTABLE AND THE PATIENT DOES NOT SURVIVE, AS WITH WHAT HAPPENED IN THIS CASE. I WOULD NOT ASSIGN ANY CAUSALITY OF THESE EVENTS TO THE IMPLANT ITSELF. 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

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN 1 SIMILAR EVENTS FOR THE LOT REFERENCED FOR THE SAME DEVICE/PATIENT, THEREFORE NO FURTHER TRENDING IS REQUIRED FOR THIS COMMONALITY. 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT#: 5510F401; TRIATHLON CR FEM COMP #4 L-CEM; LOT#: H479R. CAT#: 5551L320; TRIATHLON ASYM PATELLA A32X10; LOT#: LJK377. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    THIS PI IS FOR THE REVISION AND SUBSEQUENT PATIENT DEATH. LEFT KNEE. SUBJECT WAS ENROLLED IN THE STUDY. SUBJECT CONTACTED SITE BY PHONE TO REPORT SUDDEN ONSET OF PAIN; CLINIC VISIT ASPIRATION WAS POSITIVE FOR STAPH EPIDERMIDIS AND SUBJECT WAS TAKEN TO OR FOR I/D AND START OF LONG-TERM ANTIBIOTIC THERAPY RECEIVING ANCEF, VANCOMYCIN AND DOXYCYCLINE. SUBJECT REPORTED PAIN AND JOINT WAS ASPIRATED. CULTURE WAS POSITIVE FOR DOXYCYCLINE RESISTANT STRAIN OF STAPH AND TAKEN TO SURGERY FOR REVISION. DURING THIS HOSPITALIZATION SUBJECT HAD COMPLICATIONS OF CIRCULATORY SHOCK, ACUTE KIDNEY INJURY AND LIVER FAILURE RESULTING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320526 TRIATHLON #4 CS ALLPOLY 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 451617 07613327043259

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death| H