Triathlon 5536-B-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07613327041590), received between Mar 2, 2018 and Aug 6, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Loss of Osseointegration

  Patient problems: Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 50159828 ↗
• InjuryFeb 25, 2026Use of Device Problem

  NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24441949 ↗
• InjurySep 3, 2025Failure to Osseointegrate; Failure to Osseointegrate

  REVISED A RIGHT KNEE TRIATHLON CEMENTLESS TIBIAL BASEPLATE AND POLY DUE TO LOOSENING OF THE TIBIAL BASEPLATE COMPONENT. REVISED TO UNIVERSAL BASEPLATE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22952137 ↗
• InjuryAug 22, 2025Loss of Osseointegration; Loss of Osseointegration

  LOOSENING OF THE TIBIAL BASEPLATE OF A MAKO TKA PERFORMED IN MARCH WAS CONFIRMED. ON (B)(6) 2025 EXTRACTION SURGERY WAS PERFORMED AND A CEMENT MOLD CONTAINING ANTIBIOTICS WAS PLACED THINKING ABOUT THE POSSIBILITY OF INFECTION. A REVISION TKA IS PLANNED AT A LATER DATE. IN THE SURGEON'S OPINION, THE INITIAL SURGERY WAS PERFORMED WITH A UKA SKIN INCISION, WHICH RESULTED IN POOR VISIBILITY DURING SURGERY, CAUSING THE TIBIA TO OVERHANG MEDIALLY, AND THE LATERAL SIDE OF THE TIBIA TO SINK AFTER SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22873754 ↗
• InjuryMay 13, 2025Migration; Migration

  RIGHT-KNEE REVISION. PT. PRESENTED WITH INDICATORS OF "SUBSIDED" TRITANIUM BASEPLATE, FOLLOWING A MAKO-TKA. DR. SUSPECTED A MINOR FRACTURE OF THE TIBIA BENEATH THE BASEPLATE. HE REMOVED THE TRITANIUM BASEPLATE AND REVISED TO A CEMENTED UNIVERSAL BASEPLATE WITH BILATERAL AUGMENTS. FEMUR COMPONENT WAS LEFT IN-SITU. THE KNEE "FELT BALANCED, CLINICALLY" AND HE WENT BACK TO A CS-INSERT. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO. AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s)

  MAUDE report 22010922 ↗
• InjuryOct 30, 2024Loss of Osseointegration; Loss of Osseointegration

  LEFT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO TIBIAL LOOSENING. THE USE OF MAKO IN THE PRIMARY PROCEDURE WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS FAILURE. THE PATELLA WAS NOT RESURFACED DURING THE INDEX PROCEDURE SO IT WAS RESURFACED TODAY FOR THE FIRST TIME. THE TIBIA WAS REVISED AND FEMORAL COMPONENT WAS LEFT IN PLACE. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20569829 ↗
• InjuryJul 9, 2024Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "REVISION RIGHT TOTAL KNEE DUE TO TIBIAL COMPONENT LOOSENING. COMPONENTS REMOVED TODAY INCLUDED FEMUR, TIBIAL INSERT AND TIBIAL BASEPLATE." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19700271 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO FALL AND FRACTURE OF THE PROXIMAL TIBIA. THE USE OF MAKO ON THE PRIMARY KNEE WAS NOT THOUGHT TO HAVE ANYTHING TO DO WITH THE REVISION. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Bone Fracture(s)

  MAUDE report 19104246 ↗
• InjuryApr 2, 2024Degraded; Degraded

  DR. REVISED A LEFT TKA DONE ORIGINALLY MANUALLY DUE TO POSTERIOR WEAR OF THE TIBIAL INSERT AND METAL WEAR OF THE BASEPLATE FROM FEMORAL COMPONENT CONTACT. REVISED TO A UNIVERSAL BASEPLATE AND CEMENTED CR FEMUR. NO ALLEGATIONS MADE AGAINST THE IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 19017670 ↗
• InjuryDec 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PATIENT REVISE DUE TO METAL ALLERGY. PATELLA WAS RETAINED. USED COMPETITOR IMPLANTS AND ONE OF OUR CONES. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY."

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18307838 ↗
• InjuryAug 1, 2023Migration; Migration

  PATIENT HAD A PRIMARY KNEE REPLACEMENT ON (B)(6) 2023 AND PRESENTED TO HOSPITAL WITH PAIN AND SWELLING X-RAY SHOWED THE TIBIAL BASEPLATE HAD MOVED AND SUBSIDED. PATIENT HAD HER TIBIA REVISED SUCCESSFULLY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17438305 ↗
• InjuryMar 30, 2023Fracture; Loss of Osseointegration; Osseointegration Problem; Fracture; Loss of Osseointegration; Osseointegration Problem

  REVISED A RIGHT TRIATHLON TOTAL KNEE ORIGINALLY DONE ON (B)(6) 2022 DUE TO ASEPTIC LOOSENING, POSSIBLE INFECTION. INTRA-OP HE NOTICED WHEN REMOVING THE TIBIAL BASEPLATE, THE POSTERIOR-MEDIAL PEG WAS SHEARED OFF. DR. DIDN'T BELIEVE IT HAPPENED DUE TO HIS TECHNIQUE OF EXTRACTION AS THE BASEPLATE WAS ALREADY LOOSE. HE IS NOT SURE HOW OR WHEN IT COULD HAVE HAPPENED. HE REVISED TO A TRIATHLON TS KNEE. HE DID NOT REVISE THE PATELLA COMPONENT.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 16642403 ↗
• InjuryMar 27, 2023Loss of Osseointegration; Noise, Audible; Loss of Osseointegration; Noise, Audible

  PATIENT REPORTED JOINT LOOSENING AND AUDIBLE NOISE FOLLOWING PRIMARY TRIATHLON LEFT KNEE SURGERY. PATIENT STATED THAT SYMPTOMS STARTED "IMMEDIATELY" FOLLOWING THE (B)(6) 2020 SURGERY AND THAT THE KNEE WAS"NEVER GOOD". PATIENT STATED SHE FEELS THE LOOSENING AND DID NOT STATE WHETHER HER SURGEON CONFIRMED THE LOOSENING. PATIENT STATED THAT THE JOINT NOISE IS HEARD WHEN SHE MOVES HER "TOES UP AND DOWN".

  Patient problems: Inadequate Osseointegration

  MAUDE report 16619645 ↗
• InjuryFeb 7, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO BASEPLATE LOOSENING. A TRIATHLON TRITANIUM BASEPLATE AND 2X9 CS INSERT WERE REVISED TO A UNIVERSAL BASEPLATE AND 2X13 CS INSERT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16312816 ↗
• InjuryJan 13, 2023Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PATIENT WAS HAVING PAIN. X-RAY SHOWED A MEDIAL TIBIAL CYST. FEMUR, TIBIA AND INSERT WERE REVISED."

  Patient problems: Cyst(s); Pain

  MAUDE report 16163635 ↗
• InjuryJan 11, 2023Loss of Osseointegration; Unintended Movement; Loss of Osseointegration; Unintended Movement

  PATIENT'S TRITANIUM TIBIAL BASEPLATE WAS REVISED FOR SUBSIDENCE AND LOOSENING. TIBIAL WAS REPLACED WITH A CEMENTED UNIVERSAL BASEPLATE WITH 5MM MEDIAL AUGMENT AND SHORT CEMENTED STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16135693 ↗
• InjuryDec 21, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. [,,,] "A PATELLA COMPONENT WHICH HAS DISPLACED FROM THE BONE AND A TIBIAL COMPONENT WHICH APPEARS SUBSIDED AND IN EXTENSION". A BASEPLATE, INSERT, AND PATELLAR COMPONENT WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16021518 ↗
• InjuryJun 29, 2022Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PAIN AND DEFORMITY." A BASEPLATE, INSERT, AND PATELLAR COMPONENT WERE REVISED.

  Patient problems: Deformity/ Disfigurement; Joint Laxity; Pain

  MAUDE report 14865141 ↗
• InjuryApr 11, 2022Migration; Migration

  IT WAS REPORTED THAT THE SIZE #2 TRITANIUM BASEPLATE SUBSIDED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14073714 ↗
• InjuryJun 15, 2020Collapse; Collapse

  REP LEFT A VOICEMAIL STATING THAT THE PATIENT'S TRITANIUM BASEPLATE WAS REVISED DUE TO ANTERIOR COLLAPSE. UPDATE: "NOTES: ANTERIOR COLLAPSE OF TRI BP AT 3MO POST OP FROM IDOS. PREVIOUSLY ASYMPTOMATIC FOR PAIN/INSTABILITY. EXPLANTS UNAVAILABLE FOR RETURN, PER HOSPITAL POLICY."

  Patient problems: Injury

  MAUDE report 10152699 ↗
• InjuryMay 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD 2 WEEK POST OP EXAM WITH X-RAYS. THE X-RAY LOOKED NORMAL. 2 MONTHS LATER KNEE STARTED HURTING AND PATIENT NOTICED HER KNEE DID NOT LOOK STRAIGHT. PATIENT CAME IN FOR MORE X-RAYS, TIBIAL PLATEAU HAD FRACTURED AND WAS IN VARUS.

  Patient problems: Bone Fracture(s); Injury; Pain

  MAUDE report 10070027 ↗
• InjuryJul 2, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY, LEFT KNEE."

  Patient problems: Injury

  MAUDE report 8754453 ↗
• InjuryApr 1, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SUBSIDENCE OF THE TIBIAL BASEPLATE (POSSIBLE CAUSE OR CONTRIBUTOR FOR SUBSIDENCE NOT REPORTED TO REP). SIZE 2 BASEPLATE AND INSERT WERE REVISED TO A UNIVERSAL BASEPLATE WITH CEMENTED STEM, AND A NEW INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE INSERT.

  Patient problems: Injury

  MAUDE report 8470303 ↗
• InjuryJan 15, 2019Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "PATIENT...HAD A LEFT PRIMARY TOTAL KNEE DONE...ON (B)(6) 2017. OVER THE PAST YEAR PATIENT...ENDED UP [AT SURGEON AND HOSPITAL] WITH A CHIEF COMPLAINT OF PAIN AND INSTABILITY. [SURGEON] TOLD ME THERE WAS POSITIVE UPTAKE ON A BONE SCAN AS WELL AS MRI FOR TIBIAL BASEPLATE LOOSENING. THE PATIENT WENT INTO SURGERY ON (B)(6) 2018 AND HAD THE SIZE 2 TRITANIUM BASEPLATE AND SIZE 2X9MM POLY REPLACED WITH A CEMENTED UNIVERSAL BASEPLATE AND 12X50 STEM AND 2X16MM POLY.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8250294 ↗
• InjuryJan 10, 2019Loss of Osseointegration; Loss of Osseointegration

  ON (B)(6) 2018 INITIAL PROCEDURE DONE. (B)(6) 2018 REVISION DONE. UPDATE 26-DECEMBER-2018: REVISION SURGERY DUE TO LEFT TIBIA LOOSENING.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Injury

  MAUDE report 8235833 ↗