BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #2 11MM

    MDR report key: 13618862 · Received February 28, 2022

    Report

    Report Number
    0002249697-2022-00293
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    June 30, 2021
    Report Date
    May 20, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327336504
    PMA / PMN Number
    K172634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING CRACK/FRACTURE AND PATIENT FACTORS (PATELLA TENDON RUPTURE) INVOLVING A TRIATHLON INSERT WAS REPORTED. THE PATIENT FACTORS (PATELLA TENDON RUPTURE) EVENT WAS CONFIRMED; THE CRACK/FRACTURE 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 INFORMATION BY A CLINICAL CONSULTANT INDICATED: "CONCLUSION OF ASSESSMENT: THIS INQUIRY REPORTS THE COMPLICATION OF A RUPTURE OF THE PATELLA TENDON AFTER TOTAL KNEE ARTHROPLASTY. HOW SOON AFTER SURGERY IS UNCLEAR DUE TO DISCREPANCIES NOTED ABOVE. I CAN CONFIRM THAT THIS EVENT TOOK PLACE SINCE I WAS ABLE TO VIEW THE PRE-OP AND POST-OP RADIOGRAPHS AND THE INDEX AND REVISION OPERATION REPORT. HOWEVER, NO PATIENT IDENTIFIER IS ON THE OPERATION REPORTS BECAUSE THEY WERE REDACTED. REGARDING THE POSSIBLE ROOT CAUSE OF THIS EVENT, I CANNOT DETERMINE IT WITH CERTAINTY. CAUSES OF PATELLA TENDON RUPTURE AFTER TOTAL KNEE REPLACEMENT ARE MULTIFACTORIAL INCLUDING TRAUMA, PATIENT ACTIVITY FACTORS AND POSSIBLE DAMAGE TO THE TENDON AT SURGERY." PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR THE REPAIR OF A RUPTURED PATELLA TENDON FOLLOWING A SLIP AND FALL INCIDENT. INTRAOPERATIVELY, THE TRIATHLON INSERT WAS REVISED AS IT WAS OBSERVED TO HAVE A "NOTCH" IN IT. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT CONFIRMED THE PATELLA TENDON RUPTURE EVENT BUT WAS UNABLE TO DETERMINE ROOT CAUSE: "THIS INQUIRY REPORTS THE COMPLICATION OF A RUPTURE OF THE PATELLA TENDON AFTER TOTAL KNEE ARTHROPLASTY. [...] I CAN CONFIRM THAT THIS EVENT TOOK PLACE SINCE I WAS ABLE TO VIEW THE PRE-OP AND POST-OP RADIOGRAPHS AND THE INDEX AND REVISION OPERATION REPORT. [...] REGARDING THE POSSIBLE ROOT CAUSE OF THIS EVENT, I CANNOT DETERMINE IT WITH CERTAINTY. CAUSES OF PATELLA TENDON RUPTURE AFTER TOTAL KNEE REPLACEMENT ARE MULTIFACTORIAL INCLUDING TRAUMA, PATIENT ACTIVITY FACTORS AND POSSIBLE DAMAGE TO THE TENDON AT SURGERY." RETURN OF THE DEVICE AND/OR PHOTOGRAPHS OF THE EVENT ARE REQUIRED TO CONFIRM THE REPORTED CRACK/FRACTURE OF THE INSERT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    PATIENT HAD A INDEX RTKA IN (B)(6) 2021. PATIENT HAD A TRAUMA AND DEVELOPED A DISRUPTION OF THE EXTENSOR MECHANISM THAT REQUIRED REVISION ON (B)(6) 2021. ONLY THE POLY COMPONENT WAS EXCHANGED.

    Description of Event or Problem · 0

    PATIENT HAD A INDEX RTKA IN (B)(6)2021. PATIENT HAD A TRAUMA AND DEVELOPED A DISRUPTION OF THE EXTENSOR MECHANISM THAT REQUIRED REVISION ON (B)(6)2021. ONLY THE POLY COMPONENT WAS EXCHANGED. UPDATE 26-APRIL-2022 PER CLINICIAN REVIEW: "PRE-REVISION X-RAYS SHOW THE CEMENTLESS TRIATHLON IMPLANT. THE PATELLA IS EXTREMELY HIGH RIDING CONSISTENT WITH A RUPTURE OF THE PATELLA TENDON. [...] THE PROCEDURE PERFORMED WAS ¿ RIGHT KNEE SINGLE COMPONENT REVISION AND SECONDARY RECONSTRUCTION OF THE RIGHT KNEE PATELLA TENDON WITH MESH AUGMENTATION¿. IN THE INDICATIONS PORTION IT STATES [...] THAT THE PATIENT SUFFERED A ¿MECHANICAL SLIP AND FALL". THERE WAS A SMALL AVULSION OF THE TIBIAL TUBERCLE. IT STATES THAT THERE WAS A "NOTCH" IN THE POLYETHYLENE WHICH WAS ATTRIBUTED TO THE FALL. RECONSTRUCTION WAS CARRIED OUT USING MESH AND CEMENT AND A SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148675 X3 TRIATHLON CS INSERT #2 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5531-G-211-E LJM958 07613327336504

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| H