Triathlon 5536-B-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07613327041514), received between Mar 20, 2017 and May 19, 2026 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 30, 2022Class IIOpen, Classified

   Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.

   Z-1237-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryMay 19, 2026Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: REMOVED A TIBIA COMPONENT AND POLY INSERT. HE REPLACED BOTH WITH NEW COMPONENTS DUE TO EXCESSIVE EXTERNAL ROTATION ON PREVIOUS SURGERY. RIGHT KNEE. HOSPITAL WILL NOT RELEASE MORE INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 25213719 ↗
• InjuryAug 28, 2025Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  NO NEW INFORMATION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22919845 ↗
• InjuryJul 23, 2025Malposition of Device; Osseointegration Problem; Unintended Movement; Malposition of Device; Osseointegration Problem; Unintended Movement

  AS REPORTED: "ORIGINAL SURGERY APPROXIMATELY 1 YEAR AGO. REVISED FOR TIBIAL SUBSIDENCE." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 22580629 ↗
• InjuryMay 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE POSTERIOR MEDIAL THIRD OF THE BASEPLATE AND THE INSERT BREAKING OFF.

  Patient problems: Insufficient Information

  MAUDE report 21940909 ↗
• InjuryApr 22, 2025Mechanical Problem; Mechanical Problem

  AS REPORTED: "PATIENT REVISED DUE TO REDUCED RANGE OF MOTION IN EXTENSION. SURGEON SAID SCARRING WAS AN ISSUE. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. NEEDED TO RECUT TIBIA TO GET LEG OUT TO FULL EXTENSION, SO HE CEMENTED A UNIVERSAL BASEPLATE AND USED A STEM SINCE THE TIBIA WAS REVISED." RIGHT KNEE. A 6X9 CS INSERT AND BASEPLATE WERE REVISED TO ANOTHER 6X9 CS INSERT, BASEPLATE, AND STEM.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 21885311 ↗
• InjuryNov 16, 2024Malposition of Device; Malposition of Device

  REVISION SURGERY. PATIENT UNDERWENT TKA ON (B)(6) 2024. DEEP CUTS WITH MAKO, SURGEON TRIED TO IMPLANT A CEMENTLESS FEMUR ALTHOUGH BELIEVES THE CUTS WERE TO POOR AND ENDED UP USING A CEMENTED FEMUR. THE MEDICAL INTERVENTION ENDED UP BEING A REVISION OF THE TIBIA 2 DAYS LATER DUE TO THE TIBIAL BASEPLATE NOT BEING FULLY SEATED ON THE BONE. THE COMPLAINT AGAINST THE FEMUR WAS THE INACCURACY OF THE CUTS LEADING TO A GAP BETWEEN THE IMPLANT AND BONE WHICH LED TO THE SURGEON USING A CEMENTED IMPLANT, RATHER THAN A CEMENTLESS. SEE ATTACHED TWO POST OP X-RAYS AFTER THE PRIMARY CASE SHOWING THE ISSUES WITH THE TIBIAL BASEPLATE WHICH WAS THE REASON FOR THE REVISION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20701321 ↗
• InjurySep 3, 2024Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  LOOSENING OF A TRITANIUM TRIATHLON CEMENTLESS BASEPLATE FROM A PRIMARY TRIATHLON KNEE REPLACEMENT IN (B)(6) 2024.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20125535 ↗
• InjuryJun 3, 2024Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN OFFICE WITH KNEE PAIN AND INSTABILITY. X-RAYS REVEALED UNEVEN JOINT SPACE AND WHAT APPEARED TO BE A BROKEN BASEPLATE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19455526 ↗
• InjuryFeb 12, 2024Loss of Osseointegration; Loss of Osseointegration

  PATIENT REPORTED HE IS A DISABLED VET. IN (B)(6) 2021, HAD A LEFT KNEE REPLACEMENT. RIGHT AFTER IMPLANTATION, PATIENT HAD FEVERS FOR A WEEK. PATIENT ALSO EXPERIENCED SWELLING, PAIN, AND INFECTIONS. PATIENT CONSULTED ANOTHER DOCTOR IN (B)(6) 2023. A BONE SCAN SHOWED LOOSENING (IMPLANT NOT SPECIFIED BUT PATIENT WAS FOCUSED ON BASEPLATE). PATIENT WAS TOLD THE BASEPLATE WAS ALSO RECALLED. CONSULTING SURGEON REFERRED PATIENT TO A SPECIALIST WHO PERFORMS REVISIONS. REVISION PERFORMED (B)(6) 2024. PATIENT REPORTS HE HAS INCURRED AND IS STILL INCURRING MANY MEDICAL BILLS, AS WELL AS HAVING HAD PAIN AND SUFFERING BUT IS IN RECOVERY. PATIENT IS SEEKING COMPENSATION AND STATED HE HAS NOT YET RETAINED AN ATTORNEY.

  Patient problems: Inadequate Osseointegration; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18684038 ↗
• InjuryJun 13, 2022Malposition of Device; Naturally Worn; Malposition of Device; Naturally Worn

  REVISED A PRIMARY RIGHT KNEE TRIATHLON DUE TO MIS-BALANCING RESULTING IN MEDIAL POLY WEAR AND FEMUR RUBBING ON TIBIAL BASEPLATE. HE REVISED THE FEMUR, TIBIAL BASEPLATE AND POLY TO A COMPETITOR REVISION TOTAL KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14682441 ↗
• MalfunctionMar 29, 2022Inaccurate Information; Inaccurate Information

  PRIMARY PROCEDURE, LEFT MAKO TKA. IT WAS REPORTED THAT THE PACKAGING AND LABELS WERE FOR A SIZE 6 PRESS-FIT BASEPLATE (CATALOG AND LOT). THE IMPLANT WAS A SIZE 5 PRESS-FIT BASEPLATE (DIFFERENT CATALOG AND LOT). DISCOVERY WAS MADE WHEN THE SURGEON ATTEMPTED TO IMPLANT A SIZE 6 INSERT AND IT WOULDN'T FIT. HOSPITAL STAFF THEN CALLED OUT THE CATALOG AND LOT ON THE IMPLANT TO THE REP. SURGEON ELECTED TO LEAVE THE SIZE 5 BASEPLATE IMPLANTED AND IMPLANTED A FITTING INSERT. SURGERY COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5 MINUTES. REP REPORTED HE CAN PROVIDE PICTURES OF THE PACKAGING (BUT NOT OF THE IMPLANT AS IT WAS IN THE PATIENT/ STERILE FIELD BY THAT TIME). REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13937739 ↗
• InjuryJan 4, 2022Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO MALPOSITION AND INSTABILITY. INTRA-OPERATIVELY THE FOLLOWING WAS NOTED: SLIGHT MALPOSITION OF FEMORAL COMPONENT, WORN INSERT WITH BROKEN LOCKING WIRE, AND BROKEN TIBIAL BASEPLATE. THE BASEPLATE WAS BROKEN MEDIALLY 1/3 OF THE WAY THROUGH THE ANTERIOR MEDIAL SPIKE. THE PATIENT WAS REVISED TO A TS KNEE WITH A UNIVERSAL BASEPLATE AND STEMS.

  Patient problems: Joint Laxity

  MAUDE report 13150847 ↗
• InjurySep 9, 2021Unstable; Unintended Movement; Unstable; Unintended Movement

  PATIENT EXPERIENCED ONSET OF PAIN THAT HAS PROGRESSIVELY WORSENED OVER THE LAST 4 MONTHS. HE EXPERIENCES STIFFNESS AND SORENESS, AND HAS DIFFICULT WALKING. SOMETIMES HIS RIGHT KNEE GIVES OUT. X-RAYS SHOW WELL POSITIONED IMPLANT WITHOUT SIGNS OF LOOSENING. EXAM SHOWS HYPEREXTENSION OF 10-15 DEGREES. 10 DEGREES OF VARUS/VALGUS OPENING WITH PALPABLE CREPITUS WITH STRESS OF THE COLLATERAL LIGAMENTS. LEG LENGTHS EQUAL. NOTE: PATIENT HAD HYPEREXTENSION NOTED AT (B)(6) 2016. TIBIAL SUBSIDENCE WAS ALSO FOUND PRIOR TO THE REVISION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12446178 ↗
• InjuryAug 30, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE WITH NO KNOWN CAUSE. A SIZE 6 TRIATHLON BASEPLATE AND 6X11 CS INSERT WERE REVISED TO A SIZE 4 UNIVERSAL BASEPLATE AND 4X19 CS INSERT WITH A STEM AND AUGMENT. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP PROVIDED PRIMARY AND REVISION USAGE SHEET'S AND EXPLANT PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 12384124 ↗
• InjuryMar 30, 2021Fracture; Unstable; Fracture; Unstable

  THE POSTERIOR MEDIAL ASPECT OF OUR CEMENTLESS TITANIUM KNEE REPLACEMENT BROKE OFF INSIDE THE PATIENT. THE ANTERIOR LOCKING WIRE ALSO FRAGMENTED INTO 3 PIECES, BUT THE POLY WAS STILL LOCKED AND ENGAGED INTO THE BROKEN TIBIA, AND NOT FRACTURED. PATIENT CAME IN WITH SWELLING, PAIN AND INSTABILITY, NOTICED ON XRAY, THEN CONFIRMED AND REVISED IN SURGERY. UPDATE: "THE REVISION WAS PERFORMED BECAUSE OF THE FRACTURE OF THE TIBIAL PLATE."

  Patient problems: Failure of Implant; Pain

  MAUDE report 11590090 ↗
• InjuryJun 25, 2020Unstable; Malposition of Device; Unstable; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY AND VARUS PLACEMENT OF THE TIBIAL BASEPLATE. THE PATIENT'S ENTIRE TRIATHLON KNEE WAS REVISED TO ANOTHER TRIATHLON KNEE. THE FEMORAL COMPONENT WAS REVISED IN ORDER TO GAIN ACCESS TO THE TIBIAL COMPONENT. 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: Injury

  MAUDE report 10194101 ↗
• InjuryNov 20, 2019Failure to Osseointegrate; Failure to Osseointegrate

  AS REPORTED: "...PATIENT IS 3 YEAR POST PRIMARY LEFT TKA. DOCTOR TOLD ME THAT THE PATIENT HAS HAD PAIN AND RECURRENT EFFUSIONS AND HIS IMAGING STUDIES SUGGEST A LOOSE TIBIAL COMPONENT. THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2019. DOCTOR USED AN OSTEOTOME CIRCUMFERENTIALLY AROUND THE TIBIAL COMPONENT TO LOOSEN THE TIBIAL BASEPLATE [REVISION OPERATIVE REPORT STATES "I WAS ABLE TO PLACE AN OSTEOTOME BENEATH THE COMPONENT BETWEEN THE BONE AND IMPLANT. THIS WAS A PRESS-FIT IMPLANT ORIGINALLY. WAS ABLE TO GET THE OSTEOTOME UNDERNEATH THE COMPONENT NEARLY ALL THE WAY AROUND AND THEN IT EASILY LIFTED UP. IT WAS CLEARLY NOT WELL FIXED. THERE WAS NO BONE LOSS DURING THE REMOVAL."]...HE INSPECTED THE OTHER IMPLANTS AND SAID AFTER SURGERY THEY APPEARED TO BE WELL FIXED. HE DID A TIBIAL CLEAN UP CUT AND PREPPED FOR A UNIVERSAL CEMENTED BASEPLATE AND 12X50 STEM. HE TRIALED A 16MM PS POLY TRIAL AND ASKED FOR THE ACTUAL IMPLANT. THERE WILL BE NO EXPLANTS BECAUSE THEY WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9347931 ↗
• InjuryOct 15, 2019Osseointegration Problem; Osseointegration Problem

  PATIENT HAD PAIN SYMPTOMS. MRI SHOWED LOOSENING. PATIENT SCHEDULED FOR A REVISION.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9191853 ↗
• InjurySep 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A BROKEN TIBIAL BASEPLATE. INTRA- OPERATIVELY, SURGEON REPORTED THE EXISTENCE OF A HOLE IN THE PATIENT'S BONE DIRECTLY UNDER THE PLACE WHERE THE BASEPLATE BROKE (CAUSE AND NATURE OF THE HOLE WAS NOT REPORTED). A SIZE 6 BASEPLATE AND 6X9 CS INSERT WERE REVISED TO A SIZE 6 UNIVERSAL BASEPLATE WITH A 6X16 CS INSERT.

  Patient problems: Injury

  MAUDE report 9135239 ↗
• InjuryJul 29, 2019Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. WHILE DOING LEG PRESSES IN PHYSICAL THERAPY, PATIENT EXPERIENCED A SHARP PAIN IN THE KNEE. X-RAYS SHOWED THAT THE PATIENT SUSTAINED A MEDIAL TIBIAL PLATEAU FRACTURE. THE BASEPLATE AND INSERT WERE REVISED TO ANOTHER BASEPLATE AND TS INSERT. REP REPORTED HE CAN PROVIDE SOME ADDITIONAL IMAGES (USAGE, X-RAY).

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

  MAUDE report 8837699 ↗
• InjuryJul 2, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO" ONE YEAR STATUS POST CEMENTLESS LEFT TOTAL KNEE ARTHROPLASTY WITH ANTERIOR-POSTERIOR INSTABILITY".

  Patient problems: Injury

  MAUDE report 8754472 ↗
• InjuryMay 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO COLLAPSE OF THE TIBIAL COMPONENT. NO POSSIBLE CAUSE OR CONTRIBUTOR TO COLLAPSING WAS REPORTED TO THE REP. THE PATIENT'S KNEE CONSTRUCT WAS REVISED TO A STEMMED (FEMUR AND TIBIA) CONSTRUCT WITH CONE AUGMENTS. REP HAS PROVIDED PRE-REVISION X-RAYS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8582637 ↗
• InjuryMar 25, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LOOSE LEFT TOTAL KNEE REPLACEMENT."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8449152 ↗
• InjuryFeb 27, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE TIBIAL BASEPLATE HAVING SUBSIDED POSTERIORLY. BASEPLATE AND INSERT WERE REVISED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury

  MAUDE report 8373653 ↗
• InjuryAug 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO MECHANICAL COMPLICATIONS. SURGEON WOULD NOT ELABORATE ON THE MECHANICAL COMPLICATIONS BUT EMPHATICALLY RULED OUT THE DEVICES HAVING CAUSED OR CONTRIBUTED TO THE COMPLICATIONS. PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED TO A TRIATHLON TS CONSTRUCT. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION WILL NOT BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 7742570 ↗