Triathlon 5536-B-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07613327041491), received between Mar 14, 2017 and Jan 23, 2026 — classified as 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 39 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Malposition of Device; Migration

  THE FOLLOWING INFORMATION WAS PROVIDED: LEFT KNEE. PATIENT REVISED DUE TO TIBIA COMPONENT SUBSIDING ANTERIORLY. SURGERY SHEETS AND X-RAY ATTACHED. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 24159504 ↗
• InjuryOct 29, 2025Degraded; Degraded

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED. PATIENT PRESENTED WITH COMPLAINT OF PAIN AND A SUPERFICIAL WOUND INFECTION, AND REPORTED A PRIOR FALL AND A BUG BITE. UPON OPENING THE JOINT, METAL-STAINED TISSUE WAS OBSERVED, AS WELL AS POSTERIOR LATERAL WEAR OF THE INSERT TO THE POINT WHERE THE FEMORAL COMPONENT WAS ARTICULATING AGAINST THE BASEPLATE. SURGEON SUSPECTED THE FALL MAY HAVE DISRUPTED THE SOFT TISSUES OR SHIFTED THE IMPLANTS, CAUSING THE UNEVEN WEAR. THOUGH NO LAB RESULTS CAME BACK TO INDICATE WHETHER THE JOINT WAS INFECTED OR NOT, ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED AS A PRECAUTIONARY MEASURE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 23417538 ↗
• InjuryMay 13, 2025Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE CEMENTED TRITANIUM BASEPLATE. THE BASEPLATE AND INSERT WERE REVISED TO A UNIVERSAL BASEPLATE WITH STEM AND EXTENDER, AND A NEW INSERT. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE

  Patient problems: Inadequate Osseointegration

  MAUDE report 22010390 ↗
• InjuryMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO FAILURE OF THE BASEPLATE TO OSSEOINTEGRATE. THE BASEPLATE AND INSERT WERE REVISED TO A BASEPLATE WITH STEM AND AUGMENT, AND A NEW INSERT. 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: Inadequate Osseointegration

  MAUDE report 21630859 ↗
• InjuryNov 18, 2024Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "RIGHT-TKA REVISION PERFORMED TODAY. PT. PRESENTED WITH PAIN OF THE RIGHT-KNEE, FOLLOWING A TKA ON (B)(6) 2021. DR. SUSPECTED ASEPTIC LOOSENING OF THE IMPLANTS AND CHOSE TO REVISE THE COMPONENTS. UPON CLINICAL EVALUATION, DR. OPTED TO REVISE ONLY THE TIBIA BASEPLATE LEAVING THE FEMUR AND PATELLA IN-SITU. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES; NO FURTHER INFO AVAILABLE." CLARIFICATION FROM REP: "THE SUSPICION WAS THAT THE BASEPLATE WAS LOOSE FROM THE BONE. THE INSERT WAS STILL LOCKED-IN TO THE BASEPLATE, NO ISSUES THERE."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20704206 ↗
• InjuryAug 21, 2024Migration; Migration

  REVISED A RIGHT KNEE TRIATHLON TIBIAL BASEPLATE/INSERT DUE TO SUBSIDENCE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20009398 ↗
• InjuryJul 15, 2024Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  REVISION SCHEDULED FOR A UNCEMENTED TRIATHLON KNEE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 19747011 ↗
• InjuryFeb 27, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT HAD A LEFT TKA ON (B)(6) 2022. PATIENT DEVELOPED PAIN AND LOOSENING OF THE TIBIAL COMPONENT. PATIENT WAS REVISED ON (B)(6) 2023. ONLY THE TIBIAL COMPONENT AND THE POLY WERE EXCHANGED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18786812 ↗
• InjuryAug 24, 2023Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  PATIENT HAD INITIAL KNEE REPLACEMENT APPROXIMATELY 8 YEARS AGO. TRIATHLON TRITANIUM. PATIENT CAME TO SEE DR. IN CLINIC WITH KNEE PAIN. X RAYS WERE TAKEN AND REVEALED THAT THE TIBIAL BASEPLATE WAS BROKEN AS WELL AS THE LATERAL POSTERIOR PROXIMAL FEMUR. REVISION SURGERY WAS 7/31. ONCE THE KNEE WAS OPENED, WE NOTICED THE LOCKING WIRE ON POLY WAS BROKEN AS WELL. METAL WAS FLOATING AROUND THE JOINT AND ENDED UP UNDERNEATH THE POLY WHERE IT WAS WORK INTO THE BACKSIDE OF THE PLASTIC. ALL IMPLANTS WERE REMOVED AND REVISED WITH TRIATHLON TS. RIGHT KNEE. PER MEDICAL REVIEW OF X-RAY IMAGE DATED (B)(6) 2016: "THERE IS A FRACTURE OF THE INFERIOR POLE OF THE PATELLA PRESENT" WHICH REPORTEDLY "FULLY HEALED" WITHOUT MEDICAL INTERVENTION.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 17609797 ↗
• InjuryJun 6, 2023Migration; Migration

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "PATIENT'S TIBIA SUBSIDED SO IT WAS REVISED. EXPLANTED WERE THE TIBIAL BASEPLATE AND INSERT. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY."

  Patient problems: Insufficient Information

  MAUDE report 17076270 ↗
• InjuryNov 3, 2022Malposition of Device; Unintended Movement; Malposition of Device; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ITS GOING INTO VARUS. A TIBIAL BASEPLATE AND INSERT WERE REVISED TO A BASEPLATE WITH STEM AND A NEW INSERT. THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT. REP PROVIDED USAGE AND X-RAYS AND CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15719490 ↗
• InjuryApr 22, 2022Unstable; Unstable

  PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "ALWAYS PUTTING LIDOCAINE ON EVERY NIGHT TO GET TO SLEEP. NOT MUCH PAIN. HAVE FALLEN NUMEROUS TIMES. ALWAYS NERVOUS WALKING. KNEE STILL GIVES OUT, JUST FEELS TOO LOOSE."

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 14186456 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. PATIENT COMPLAINED OF PAIN AFTER A FALL AND WAS FOUND TO HAVE A TIBIAL PLATEAU FRACTURE. THE BASEPLATE AND INSERT WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 13400567 ↗
• InjuryJul 19, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. THE PATIENT WAS REVISED FROM A CS KNEE TO A TS KNEE. REP CONFIRMED THAT EXPLANTS MAY BE AVAILABLE FOR RETURN, BUT OTHERWISE NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12189596 ↗
• InjuryMar 3, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT MAKO KNEE WAS REVISED DUE TO PAIN. NO POSSIBLE CAUSE OR CONTRIBUTOR FOR PAIN WAS REPORTED. INTRA-OPERATIVELY, THE TIBIAL COMPONENT WAS FOUND TO BE A TINY BIT LOOSE, BUT THE BASEPLATE STILL REQUIRED CONSIDERABLE EFFORT TO REMOVE. A SIZE 4 BASEPLATE AND 4X9 CS INSERT WERE REVISED TO A SIZE 4 UNIVERSAL BASEPLATE WITH STEM, AND 4X16 CS INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11406023 ↗
• InjuryJan 8, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. THE SURGEON'S ORIGINAL PLAN WAS TO REVISE A 4X19 CS INSERT TO A 4X22 CS INSERT. HOWEVER, THE SURGEON WAS NOT SATISFIED WITH THE STABILITY OF THE JOINT AND REVISED THE PATIENT'S KNEE FROM A CR KNEE TO A TS KNEE. THE PATIENT'S RESURFACED PATELLA WAS NOT REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED DEVICES, PROVIDED THE PRIMARY USAGE SHEET, AND ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Joint Laxity

  MAUDE report 11140815 ↗
• InjuryDec 20, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. SURGEON REPORTED THAT THE COMPONENTS HAD SETTLED INTO VARUS ALIGNMENT. THE PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED TO COMPETITOR COMPONENTS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT OR PATELLAR COMPONENT. REP ALSO REPORTED HE CAN SUPPLY A PICTURE OF THE EXPLANTS, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11043061 ↗
• InjuryOct 28, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND A TIBIAL COMPONENT WHICH SUBSIDED LATERALLY. A SIZE 4 TIBIAL COMPONENT AND 4X11 CS INSERT WERE REVISED TO A SIZE 3 UNIVERSAL BASEPLATE WITH AUGMENTS AND STEM, AND A 3X16 CS INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Pain

  MAUDE report 10751784 ↗
• MalfunctionSep 22, 2020Defective Component; Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information

  PRIMARY PROCEDURE, LEFT KNEE. THE FOLLOWING SEQUENCE OF EVENTS WERE REPORTED: A 4X11 CS INSERT WOULD NOT LOCK ON THE BASEPLATE. SURGEON REMOVED THE INSERT, INSPECTED THE BASEPLATE TO ENSURE NO SOFT TISSUE WAS IMPINGING, AND USED A SECOND 4X11 CS INSERT, WHICH ALSO WOULD NOT LOCK. THE INSERT WAS REMOVED, THE SITE WAS TRIPLE-CHECKED TO ENSURE THERE WAS NO SOFT TISSUE IMPINGEMENT, AND A THIRD 4X11 CS INSERT WAS USED. THE SURGEON FELT THE INSERT WAS SITTING .5MM TO 1MM PROUD. A NEW BASEPLATE WAS OPENED AND A 4X9 INSERT WAS LOCKED INTO IT AS THERE WAS ONLY ONE 4X11 CS INSERT LEFT IN THE HOSPITAL. THIS CONSTRUCT WAS USED TO VISUALLY COMPARE THE IN-SITU BASEPLATE AND INSERT AND THE 4X11 WAS DEEMED TO BE PROUD. THE 4X11 INSERT AND BASEPLATE IN SITU WERE REMOVED, THE 4X9 INSERT (WHICH WAS NEVER IN CONTACT WITH THE PATIENT) WAS SEPARATED FROM THE BASEPLATE AND DISPOSED. THE NEW BASEPLATE WAS IMPLANTED, AND THE FOURTH 4X11 CS INSERT LOCKED INTO THE BASEPLATE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 30 MINUTES WITH USE OF TOURNIQUET. THE SURGEON (WHO IS A MAKO CONSULTANT) WANTS THE WASTED BASEPLATE AND 4X11 CS INSERTS INVESTIGATED, AND HE WANTS THE RESULTS. REP, WHO WA

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10566220 ↗
• InjuryApr 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. PATIENT'S TIBIAL BASEPLATE AND 4X9 PS INSERT WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 9929555 ↗
• InjuryMar 24, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT REPORTING PAINFUL TKA. SUSPECTED LOOSE TRITANIUM TIBIAL COMPONENT. PATIENT WAS REVISED.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9872143 ↗
• InjuryMar 20, 2020Migration; Migration

  PATIENT PRESENTED AT DOCTOR'S OFFICE WITH COLLAPSED RIGHT ANTERIOR TIBIA. DOCTOR SCHEDULED FOR SURGERY TO REVISE TIBIAL COMPONENT. TIBIAL INSERT AND FEMORAL COMPONENT REPLACEMENT.

  Patient problems: Injury

  MAUDE report 9859476 ↗
• InjuryMar 13, 2020Unstable; Device Misassembled During Manufacturing /Shipping; Insufficient Device Problem Information; Unstable; Device Misassembled During Manufacturing /Shipping; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2015 WHERE A TRIATHLON KNEE SYSTEM WITH A TRIATHLON X3 TIBIAL BEARING INSERT WAS PLACED INTO HIS RIGHT KNEE. IT IS ALLEGED THAT THE PATIENT SUFFERED FROM PERSISTENT MILD VARUS-VALGUS LAXITY, MILD SWELLING, DIFFUSE JOINT LINE PAIN AND X-RAYS REVEALED ASYMMETRY IN THE TIBIAL POLY. ALLEGEDLY HE UNDERWENT POLY TIBIA REVISION SURGERY ON (B)(6) 2019 AND AFTER THE SURGERY THE SURGEON TOLD THE PATIENT THAT "DURING THE SURGERY HE DISCOVERED THAT STRYKER HAD PLACED THE WRONG COMPONENTS IN THE PACKAGE FOR THE ORIGINAL TOTAL KNEE REPLACEMENT SURGERY BACK IN 2015".

  Patient problems: Injury; Joint Swelling; Pain; Swelling

  MAUDE report 9828908 ↗
• InjuryFeb 19, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S PS KNEE CONSTRUCT WAS REVISED TO A TS KNEE CONSTRUCT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9728342 ↗
• InjuryJan 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "THE PATIENT('S RIGHT KNEE) WAS REVISED DUE TO A METAL ALLERGY ACCORDING TO THE SURGEON. REVISION COMPONENTS INCLUDED WERE COMPETITOR DEVICES, AS WELL AS STRYKER CONES. COMPONENTS REMOVED WERE THE FEMUR, INSERT, TIBIAL COMPONENT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 9603202 ↗