BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM

    MDR report key: 12808414 · Received November 14, 2021

    Report

    Report Number
    0002249697-2021-01881
    Event Type
    Injury
    Date Received
    November 14, 2021
    Date of Event
    February 5, 2021
    Report Date
    January 17, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327027303
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: DEVICE INFORMATION AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL, DIMENSIONAL, FUNCTIONAL AND MATERIAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE NOT RETURNED CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT AND STERILE LOT. CONCLUSIONS: ALL STRYKER PRODUCTS SOLD AS STERILE ARE VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL (SAL) OF 10^-6 IN ACCORDANCE TO APPLICABLE ISO STANDARDS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING PATHOLOGY REPORTS, OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: 5512-F-502; TRI TS FEMUR SZ5 RIGHT; GGB9E; 5521-B-500; TRI TS BASEPLATE SIZE 5; GGS4GA; 5550-G-339-E; TRIATHLON SYMMETRIC X3 PATELLA; TY1P; 5549-A-672; TRIATHLONCTRFEMCONEAUG SZ 7&8R; L70M1; 5549-A-150; TRIATHLON SYM CONE AUG SZ E; HHP8; 5560-S-212; TRI CEMENTED STEM 12MMX100MM; 0090874J; 5543-A-500; TRI POST AUGMENT SZ5 5MM; ERY7E; 5540-A-502; TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 5 RIGHT; DZO7E; 5546-A-501; TRI LM/RL TIB AUG SZ5 10MM; ERFCA3D; 5560-S-215; TRIATHLON CEMENTED STEM-15MM X 100MM; 0077017A; 5546-A-502; TRI RM/LL TIB AUG SZ5 10MM; ERFFM5D. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: 5512-F-502; TRI TS FEMUR SZ5 RIGHT; GGB9E. 5521-B-500; TRI TS BASEPLATE SIZE 5; GGS4GA. 5550-G-339-E; TRIATHLON SYMMETRIC X3 PATELLA; TY1P. 5549-A-672; TRIATHLONCTRFEMCONEAUG SZ 7&8R; L70M1. 5549-A-150; TRIATHLON SYM CONE AUG SZ E; HHP8. 5560-S-212; TRI CEMENTED STEM 12MMX100MM; 0090874J. 5543-A-500; TRI POST AUGMENT SZ5 5MM; ERY7E. 5540-A-502; TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 5 RIGHT; DZO7E. 5546-A-501; TRI LM/RL TIB AUG SZ5 10MM; ERFCA3D. 5560-S-215; TRIATHLON CEMENTED STEM-15MM X 100MM; 0077017A. 5546-A-502; TRI RM/LL TIB AUG SZ5 10MM; ERFFM5D. 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

    THIS PI IS FOR THE REVISION ON (B)(6) 2021. PATIENT HAD BILATERAL INDEX TKA (OUTSIDE OF CORS SCOPE). PATIENT IS ADMITTED WITH PAIN AND BILATERAL KNEE PJI. UNDERGOES BILATERAL REVISION ON (B)(6) 2021 WITH ALL COMPONENTS EXCHANGED, AND ANTIBIOTIC LOADED CEMENT FOR TREATMENT. PATIENT RETURNS FOR PERSISTENT RIGHT KNEE PJI ON (B)(6) 2021 FOR AN I&D AND POLY EXCHANGED REPORTED AS CORS PER 13236KNEE. PATIENT RETURNS WITH PERSISTENT PJI, UNDERGOES NEW REVISION WITH AN I&D AND A POLY EXCHANGE ONLY. REPORTED AS CORS PER 13236(2). PATIENT RETURNS (B)(6) 2021 WITH PERSISTENT PJI, UNDERGOES ANOTHER REVISION WITH AN I&D AND A POLY EXCHANGE ONLY.

    Description of Event or Problem · 0

    THIS PI IS FOR THE REVISION ON (B)(6) 2021. PATIENT HAD BILATERAL INDEX TKA (OUTSIDE OF CORS SCOPE). PATIENT IS ADMITTED WITH PAIN AND BILATERAL KNEE PJI. UNDERGOES BILATERAL REVISION ON (B)(6) 2021 WITH ALL COMPONENTS EXCHANGED, AND ANTIBIOTIC LOADED CEMENT FOR TREATMENT. PATIENT RETURNS FOR PERSISTENT RIGHT KNEE PJI ON (B)(6) 2021 FOR AN I&D AND POLY EXCHANGED REPORTED AS CORS PER (B)(4) KNEE. PATIENT RETURNS WITH PERSISTENT PJI, UNDERGOES NEW REVISION WITH AN I&D AND A POLY EXCHANGE ONLY. REPORTED AS CORS PER (B)(4). PATIENT RETURNS (B)(6) 2021 WITH PERSISTENT PJI, UNDERGOES ANOTHER REVISION WITH AN I&D AND A POLY EXCHANGE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706713 NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5537-G-509 N43N9A 07613327027303

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H