Triathlon 5536-B-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 07613327041484), received between Jul 10, 2017 and Mar 3, 2026 — classified as 47 injuries.

The most frequently reported specific device problem is “Migration” (10 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND FLEXION INSTABILITY. INTRA-OPERATIVELY, SIGNIFICANT INSERT WEAR WAS NOTED POSTERIORLY/ MEDIALLY, AND A PORTION OF THE BASEPLATE WAS BROKEN OFF (SURGEON REPORTED POSSIBLE CAUSE/ CONTRIBUTOR WAS THAT THE BASEPLATE WAS IMPLANTED WITH TOO MUCH POSTERIOR SLOPE). A CR/ CS KNEE WAS CONVERTED TO A TS KNEE (PATELLAR COMPONENT WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24494749 ↗
• InjurySep 17, 2025Failure to Osseointegrate; Failure to Osseointegrate

  REVISED A LEFT CR/CS CEMENTLESS TRIATHLON DUE TO TIBIAL LOOSENING. HE REVISED TO A CEMENTED PS TRIATHLON WITH TIBIAL STEM AND AUGMENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23080598 ↗
• InjuryJul 7, 2025Unstable; Osseointegration Problem; Migration; Unstable; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO FLEXION INSTABILITY, TIBIAL SUBSIDENCE AND TIBIAL LOOSENING. A CR/ CS KNEE WAS CONVERTED TO TS KNEE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Joint Laxity

  MAUDE report 22414539 ↗
• InjuryFeb 18, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POSTERIOR SUBSIDENCE OF THE TIBIAL BASEPLATE. A CR KNEE WAS CONVERTED TO A PS KNEE. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21394565 ↗
• InjurySep 16, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. ADDITIONALLY, SURGEON REPORTED HE WAS NOT SATISFIED WITH COMPONENT ALIGNMENT. A CR/ CS KNEE WAS CONVERTED TO A TS KNEE (PATELLAR COMPONENT WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 20233631 ↗
• InjuryJun 13, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO TIBIAL LOOSENING. A CR/ CS KNEE WAS CONVERTED TO A TS KNEE WITH TRIATHLON REVISION BASEPLATE. REP CAN PROVIDE INFORMATION ON THE REVISED IMPLANTS, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19526496 ↗
• InjuryMay 28, 2024Unstable; Unstable

  PATIENT FELL SEVERAL WEEKS POST PRIMARY WITH SUBSEQUENT ISSUES WITH STABILITY RESULTING IN REPEATED FALLS LEADING TO REVISION. PER REVISION OP REPORT: "SURGICAL FINDINGS: INSTABILITY, LOOSE FEMUR AND TIBIAL COMPONENT WITH FIBROUS IN-GROWTH".

  Patient problems: Joint Laxity

  MAUDE report 19403256 ↗
• InjuryMay 9, 2024Mechanical Problem; Mechanical Problem

  AS REPORTED: "PATIENT'S RIGHT KNEE WAS REVISED DUE TO LACK OF RANGE OF MOTION. NO OTHER INFO AVAILABLE DUE TO HOSPITAL POLICY." REP CONFIRMED A BASEPLATE AND INSERT WERE REVISED (STEM FROM INDEX PROCEDURE WAS ON THE FEMORAL COMPONENT).

  Patient problems: Loss of Range of Motion

  MAUDE report 19276978 ↗
• InjuryMar 28, 2024Unstable; Migration; Unstable; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN, INSTABILITY, AND SUBSIDENCE OF THE TIBIAL BASEPLATE (APPROXIMATELY 1 CM INTO VARUS). A CR/ CS KNEE WAS CONVERTED TO A TS KNEE WITH AUGMENTS, STEMS AND A PATELLAR COMPONENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19001036 ↗
• InjuryMar 22, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED BECAUSE THE KNEE WAS IN VARUS. A TRIATHLON PS KNEE WAS REVISED TO A TRIATHLON TS KNEE WITH STEMS AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 18957856 ↗
• InjuryMar 1, 2024Degraded; Fracture; Unstable; Degraded; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO GLOBAL INSTABILITY AND PAIN. INTRA-OPERATIVELY, THE FOLLOWING WERE OBSERVED: THE LOCKING WIRE OF THE INSERT BROKE, AND THE INSERT DISLODGED FROM THE BASEPLATE. THE FEMORAL COMPONENT WAS ARTICULATING POSTERIORLY, CAUSING INSERT WEAR AND METALLOSIS DUE TO ARTICULATING WITH THE BASEPLATE. THE BASEPLATE'S POSTERIOR MEDIAL PORTION WAS BROKEN OFF. PATIENT'S ACTIVITY LEVEL WAS NORMAL, NO TRAUMA REPORTED. THE PATIENT'S CR KNEE (INCLUDING PATELLAR COMPONENT) WAS CONVERTED TO A TS KNEE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 18814725 ↗
• InjuryFeb 26, 2024Unstable; Unstable

  PATIENT HAD A RIGHT TKA ON (B)(6) 2019. THE PATIENT DEVELOPED MECHANICAL INSTABILITY AND WAS REVISED ON (B)(6) 2023. ALL COMPONENTS WHERE EXCHANGED EXCEPT THE PATELLA.

  Patient problems: Joint Laxity

  MAUDE report 18785565 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO PAIN AROUND THE TIBIAL IMPLANT. ON X-RAY THERE WAS THE APPEARANCE OF LOOSENING AROUND THE TIBIA. IN SURGERY THE TIBIA WAS NOT LOOSE BUT THE DECISION WAS MADE TO REVISE IT DUE TO THE PATIENT¿S COMPLAINT OF PAIN IN THAT AREA. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Pain

  MAUDE report 18279589 ↗
• InjuryNov 1, 2023Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND SUSPECTED BONE LOOSENING BASED ON INDICATIONS SEEN IN BONE SCAN. INTRA-OPERATIVELY, THE IMPLANTS DID NOT APPEAR TO BE GROSSLY LOOSE. A TIBIAL BASEPLATE AND INSERT WERE REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18048621 ↗
• InjuryOct 26, 2023Migration; Migration

  REVISED A TIBIAL INSERT AND CEMENTLESS BASEPLATE DUE TO PATIENT FALLING AND TIBIA SUBSIDING MEDIALLY. REPLACED WITH A UNIVERSAL BASEPLATE WITH STEM.

  Patient problems: Fall

  MAUDE report 18016880 ↗
• InjurySep 24, 2023Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO TIBIAL LOOSENING AND IMPLANT COLLAPSING INTO VALGUS. SURGEON SUSPECTED THE PATELLAR COMPONENT WAS LOOSE. INTRA-OPERATIVELY, THE PATELLAR COMPONENT WAS NOT NOTED TO BE LOOSE BUT THE SURGEON DECIDED TO REPLACE IT OUT OF AN ABUNDANCE OF CAUTION. THE PATELLAR COMPONENT, BASEPLATE, AND INSERT WERE REVISED. SURGEON REVISED TO A THICKER INSERT TO ACCOUNT FOR THE ADDITIONAL RESECTED BONE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17805303 ↗
• InjuryMar 29, 2023Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  THIS PI FOR THE RIGHT KNEE AS REPORTED BY THE PATIENT:: RIGHT KNEE: (B)(6), 2018: PRIMARY RIGHT KNEE STRYKER IMPLANT (B)(6) 2019: REVISION, RIGHT KNEE, STRYKER IMPLANT - REASON UNKNOWN POSSIBLE SECOND REVISION OF THE RIGHT KNEE, DATE TO DETERMINE -REASON UNKNOWN- (B)(6) 2023: DAUGHTER CONFIRMED THAT RIGHT KNEE REVISION WILL BE IN 2-3 MONTHS. THE SURGEON WOULD LIKE TO MINIMIZE THE RISK OF BLOOD CLOTS BY WAITING TO DO THE REVISION. LEFT KNEE: (B)(6) 2020:PRIMARY LEFT KNEE STRYKER IMPLANT (B)(6), 2022: PATIENT REPORTS PAIN, A BONE SCAN WAS PERFORMED (B)(6) 2023: DR CONFIRMED THAT HER IMPLANTS ¿FELL APART.¿ LEFT KNEE REVISION REQUIRED, REVISION SCHEDULED FOR (B)(6) 2023. DAUGHTER IS NOT SURE IF THAT IS EVEN POSSIBLE (IMPLANTS FALLING APART) AND WOULD LIKE IT INVESTIGATED. (B)(6) 2023 UPDATE : DAUGHTER CONFIRMED HER MOTHER HAD REVISION SURGERY OF THE LEFT KNEE ON (B)(6) 2023 AND SHE IS CURRENTLY EXPERIENCING INCREASED PAIN SINCE THE PROCEDURE. DAUGHTER STATED HER MOTHER'S QUALITY LIFE HAS DIMINISHED SINCE THE MULTIPLE REVISIONS. UPDATE: (B)(6) 2023. PER REVISION OP REPORT, REVISION WAS DUE TO ASEPTIC TIBIAL LOOSENING. ONLY THE BASEPLATE AND INSERT WERE REVISED UPDATE: PER OP REPORT: PAT

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 16633578 ↗
• InjuryDec 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUBSIDENCE OF THE TIBIAL BASEPLATE AND PCL ISSUES. FEMORAL COMPONENT, INSERT, AND BASEPLATE WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 15892157 ↗
• InjuryAug 22, 2022Unintended Movement; Migration; Unintended Movement; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "PATIENT HAD HER TIBIA AND POLY REVISED DUE TO SUBSIDENCE." REP PROVIDED AN X-RAY, PRIMARY AND REVISION USAGE SHEETS. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15263738 ↗
• InjuryJul 29, 2022Osseointegration Problem; Osseointegration Problem

  REVISION WAS PERFORMED FOR COMPLAINT OF PAIN AND OBSERVATION OF POSSIBLE TIBIAL LOOSENING ON BONE SCAN. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL." SPOKE TO REP. INTRA-OPERATIVELY, SURGEON REPORTED THERE WAS SOME IMPLANT LOOSENING. A BASEPLATE AND 3X10 CS INSERT WERE REVISED TO A BASEPLATE WITH STEM, 3X14 CS INSERT, AND THE PATIENT'S NATIVE (BONE) PATELLA WAS RESURFACED.

  Patient problems: Pain

  MAUDE report 15127641 ↗
• InjuryApr 25, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUBSIDENCE OF THE TIBIAL BASEPLATE (POSSIBLE CAUSE OR CONTRIBUTOR FOR SUBSIDENCE NOT REPORTED TO REP). A BASEPLATE AND POLY INSERT WERE REVISED TO A BASEPLATE, STEM, AND POLY INSERT.

  Patient problems: Insufficient Information

  MAUDE report 14198017 ↗
• InjuryFeb 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISED A TRIATHLON CEMENTLESS LEFT TOTAL KNEE DUE TO A PATIENT FALL AND PERIPROSTHETIC FRACTURE. HE REMOVED THE FEMORAL AND TIBIAL COMPONENTS AND REPLACED WITH A STRYKER TIBIAL CONE AND COMPETITOR TOTAL KNEE REVISION IMPLANTS. SMALL FRACTURE IN THE TIBIA.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 13423228 ↗
• InjuryJan 31, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIAL BASEPLATE. INTRA-OPERATIVELY, THE LOCKING WIRE OF THE INSERT WAS OBSERVED TO HAVE BROKEN. THOUGH THE FEMORAL COMPONENT WAS WELL-FIXED, IT WAS REVISED IN ORDER TO ACCESS THE BASEPLATE. THE PATELLA WAS RETAINED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13404979 ↗
• InjuryJan 27, 2022Loss of Osseointegration; Loss of Osseointegration

  PATIENT REPORTED SHE HAD A LEFT TKA ON (B)(6) 2018. PATIENT STATED THAT SINCE HER SURGERY SHE HAS EXPERIENCED SWELLING AND PAIN. PATIENT HAD X-RAYS DONE AND WAS TOLD BY HER SURGEON THAT HER KNEE WAS LOOSE AND SHE REQUIRES REVISION SURGERY.

  Patient problems: Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 13366028 ↗
• InjuryJan 12, 2022Unstable; Unintended Movement; Unstable; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION INSTABILITY, GLOBAL INSTABILITY, AND TIBIAL BASEPLATE SUBSIDENCE. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: THE LOCKING WIRE OF THE INSERT WAS BROKEN AT BOTH LOCKING POINTS OF THE BASEPLATE, POSTEROMEDIAL WEAR WAS NOTED ON THE INSERT, AND A PIECE OF THE INSERT (ABOUT THE SIZE OF A DIME) HAD BROKEN OFF THE POSTEROMEDIAL PORTION. THE BASEPLATE, INSERT, AND FEMORAL COMPONENT WERE REVISED TO COMPETITOR DEVICES (NO ALLEGATIONS WERE MADE AGAINST THE FEMORAL COMPONENT), THE PATELLAR COMPONENT WAS RETAINED.

  Patient problems: Joint Laxity

  MAUDE report 13235391 ↗