Triathlon 5510-F-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07613327040289), received between Mar 30, 2017 and Nov 21, 2025 — classified as 29 injuries, 4 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A CR FEMUR AND CS INSERT WERE REVISED TO A TS FEMUR AND INSERT WITH STEM AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 23616283 ↗
• InjuryJul 23, 2025Use of Device Problem; Use of Device Problem

  FOR CASE IN WHICH CEMENTLESS FEMORAL IMPLANT WAS TO BE USED, THE CEMENTED FEMORAL IMPLANT WAS OPENED AND PLACED WITHOUT CEMENTING AS IT WAS, AND THE WOUND WAS CLOSED. AFTER THE WOUND WAS CLOSED, IT WAS DISCOVERED THAT THE WRONG IMPLANT HAD BEEN PLACED. THE PATIENT WAS REANESTHETIZED AND THE CEMENTED FEMORAL IMPLANT WAS REPLACED WITH A CEMENTLESS FEMORAL IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22581240 ↗
• InjuryMay 1, 2025Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPORTED: "DURING A MAKO TKA PROCEDURE A CEMENTED FEMORAL COMPONENT WAS OPENED AND IMPLANTED ON THE PATIENT UNDER THE ASSUMPTION THAT IT WAS A CEMENTLESS COMPONENT. THE CEMENTED IMPLANT WAS MIXED UP ON SHELF WITH THE CEMENTLESS IMPLANTS WHICH WAS THEN BROUGHT INTO THEATRE. THE IMPLANTS WERE CHECKED AND SHOWN TO THE SENIOR REGISTRAR WHO WAS LEADING THE SURGERY, AND THE SCRUB NURSE, AND WERE CONFIRMED TO BE CORRECT. THE FACT THAT IT WAS A CEMENTED FEMORAL COMPONENT WAS NOT NOTICED BY THE REP, THE REGISTRAR, OR NURSES. THE IMPLANT WAS OPENED AND IMPLANTED ON THE PATIENT WITH NO CEMENT AS IT WAS THOUGHT TO BE CEMENTLESS. THE LACK OF PA COATING ON THE COMPONENT WAS NOT NOTICED DURING IMPLANT PREPARATION BY NURSES, SUPERVISING CONSULTANT OR REGISTRAR. THE CASE WAS COMPLETED AND THE ERROR WAS NOT NOTICED UPON CHECKING THE IMPLANT STICKERS WHEN SUBMITTING USAGE AS THE STICKERS DO NOT CONTAIN ANY INFORMATION REGARDING CEMENTED/ CEMENTLESS. THE ISSUE WAS NOTICED 2-3 HOURS LATER BY THE REP WHEN CHECKING THE IMPLANT TROLLEY AND REALISING THAT THE CEMENTLESS COMPONENT WAS STILL ON SHELF, AND THEN FINDING THE IMPLANT BOX THAT HAD BEEN OPENED AND DISPOSED OF. THE SURGEON AND THE

  Patient problems: Insufficient Information

  MAUDE report 21940907 ↗
• InjuryJun 14, 2024Use of Device Problem; Use of Device Problem

  ON 5/21, AFTER THE ROBOT WAS REGISTERED, PULLED IMPLANTS AND BROUGHT INTO THE ROOM. COMPLETED CASE, CUTS AND TRIALING WENT SMOOTHLY. SHOWED IMPLANTS TO DR. AND HE CONFIRMED WANTING TO OPEN IMPLANT BOXES AND VERBALIZED EXPIRATION DATE TO DOCTOR. OPENED IMPLANTS AND HANDED TO CIRCULATING RN TO GIVE TO SCRUB TECH. OPENED CEMENTED CR FEMUR AND CS INSERT WITH PRESSFIT TRIATHLON TRITANIUM BASEPLATE - IMPLANTED A CEMENTED FEMUR FOR A PRESSFIT PATIENT. SALES REP NOTICED THE ERROR THE FOLLOWING DAY 5/22. PATIENT HAS TO COME BACK ON (B)(6) TO HAVE THE FEMUR IMPLANT REMOVED AND PROPER IMPLANT PUT IN.

  Patient problems: Insufficient Information

  MAUDE report 19536539 ↗
• InjuryJan 24, 2024Osseointegration Problem; Osseointegration Problem

  THE FOLLOWING WAS REPORTED: REVISED A FEMUR AND POLY DUE TO FEMORAL LOOSENING OF A CEMENTED TRIATHLON. RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18569485 ↗
• InjuryJan 8, 2024Unstable; Unstable

  RIGHT TOTAL KNEE REVISION DUE TO JOINT LAXITY. CONVERTED CR KNEE TO PS KNEE CONSTRUCT. SWAPPED FEMORAL COMPONENT AND TIBIAL BEARING INSERT ONLY.

  Patient problems: Joint Laxity

  MAUDE report 18462784 ↗
• InjuryNov 28, 2023Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED VIA MEDWATCH MW5147241: CALLER STATED THAT HE WAS IMPLANTED WITH A STRYKER KNEE IMPLANT 2020. THE IMPLANT WAS REVISED 2023 BECAUSE IT WAS LOOSE AND DEFECTIVE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 18214503 ↗
• InjuryJun 19, 2023Loss of Osseointegration; Loss of Osseointegration

  SUBJECT HAD REVISION OF STRYKER COMPONENTS ON (B)(6) 2021 UPON ENROLLMENT IN TRIATHLON CONES (76) STUDY. SUBJECT HAD A PATELLA IMPLANTED ON (B)(6) 2018 THAT WAS NOT REVISED. REVISION WAS OBSERVED DURING ROUTINE MONITORING VISIT UPON REVIEW OF PREVIOUS IMPLANT INFORMATION. PRE-OP IMAGES PROVIDED BY SITE TO SPONSOR IN INTELEMAGE. UPDATE: REASON FOR REVISION: ASEPTIC FAILURE OF THE KNEE -IMPLANT MIGRATION, LOOSENING OF FEMORAL AND TIBIAL COMPONENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17151714 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF PAIN FOLLOWING 2 FALLS. PRE-OPERATIVELY, SURGEON REPORTED TIBIAL FRACTURE AND BASEPLATE SUBSIDENCE. THE BASEPLATE, INSERT, AND FEMORAL COMPONENT WERE REVISED. REP CONFIRMED FEMUR WAS REVISED TO CONVERT TO A PS KNEE, AND THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT. THE PATELLAR COMPONENT WAS RETAINED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 16951387 ↗
• InjuryFeb 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. INTRA-OPERATIVELY, THE POSTERIOR ASPECT OF THE MEDIAL CONDYLE OF THE FEMORAL COMPONENT WAS BROKEN FROM THE REST OF THE IMPLANT, RESULTING IN DAMAGE TO THE INSERT. A SIZE 3 CR FEMUR AND SIZE 3 CR INSERT WERE REVISED TO A SIZE 4 TS FEMUR AND ANOTHER INSERT. INCIDENT OCCURRED DURING A REVISION TOTAL KNEE ARTHROPLASTY IN WHICH THE FEMORAL COMPONENT (5510-F-402) WAS FRACTURED AT THE MEDIAL DISTAL SURFACE. AS WELL AS SIGNIFICANT WEAR ON THE MEDIAL BEARING SURFACE OF THE POLYETHYLENE. THE TIBIAL BASEPLATE (5520-B-300) REMAINED WELL-FIXED, THEREFORE WAS NOT REVISED. THE FEMORAL COMPONENT WAS REVISED WITH A RT TS SIZE 4 FEMUR COMPRISED OF A 5MM AUGMENT DISTAL MEDIAL, 5MM AUGMENT POSTERIOR MEDIAL, AND A 15MM X 50MM CEMENTED STEM. THE POLYETHYLENE WAS REVISED WITH A SIZE 3 X 16MM POSTERIOR STABILIZED INSERT.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13609947 ↗
• InjurySep 21, 2021Unstable; Unstable

  THIS PI IS FOR REVISION SURGERY IN 2015. "IN 2015 PATIENT WAS SEEN AGAIN COMPLAINING OF PAIN AND INSTABILITY IN THE RIGHT TOTAL KNEE REPLACEMENT. ON (B)(6) 2015 SHE UNDERWENT REVISION OF THE FEMORAL AND TIBIAL COMPONENTS OF HER RIGHT TOTAL KNEE REPLACEMENT. IT IS UNCLEAR WHY A REVISION OF THE COMPONENTS WAS PERFORMED. NO MENTION WAS MADE OF TRYING TO CORRECT THE INSTABILITY WITH ANOTHER POLYETHYLENE EXCHANGE. THE SURGEON USED COMPONENTS WITH A ROTATING PLATFORM REVISION TRAY WITH A FEMORAL SLEEVE AND ADAPTER AND THE TIBIA HAD A METAPHYSEAL SLEEVE. THE PATELLA WAS LEFT IN PLACE."

  Patient problems: Joint Laxity; Pain

  MAUDE report 12506599 ↗
• InjuryJan 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE MEDIAL CONDYLE OF THE FEMORAL COMPONENT BREAKING OFF. A CR FEMUR AND CS INSERT WERE REVISED TO A TS FEMUR AND NEW INSERT. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP REPORTED HE CAN SEND AN EXPLANT PICTURE AND ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11155278 ↗
• InjuryFeb 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  APPROXIMATELY 4 MONTHS AFTER SURGERY, PATIENT FELL, FRACTURING MEDIAL CONDYLE OF RIGHT FEMUR. IT APPEARED THAT IT WASN'T HEALING. SO SCHEDULED FOR REVISION OF FEMORAL COMPONENT AND LINER SWAP.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9733722 ↗
• InjuryOct 7, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  REVISION ASEPTIC LOOSENING.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury

  MAUDE report 9163858 ↗
• InjurySep 27, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO MID-FLEXION INSTABILITY. A SIZE 4 CR FEMORAL COMPONENT AND 3X11 CS INSERT WERE REVISED TO A SIZE 4 TS FEMORAL COMPONENT WITH A STEM AND FOUR AUGMENTS, AND A 3X9 TS INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE LINER. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9130759 ↗
• InjurySep 19, 2019Unstable; Unstable

  PATIENT ORIGINALLY HAD A RIGHT TOTAL KNEE DONE BY DR ON (B)(6) 2016. NOW NEEDS REVISED DUE TO PAIN AND INSTABILITY.

  Patient problems: Injury; Pain

  MAUDE report 9087583 ↗
• InjuryJul 2, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "ASEPTIC LOOSENING RIGHT TOTAL KNEE REPLACEMENT"

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8754250 ↗
• InjuryJul 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "PATELLOFEMORAL ARTHRITIS, POST PARTIAL TOTAL RIGHT KNEE REPLACEMENT."

  Patient problems: Arthritis; Injury

  MAUDE report 8753510 ↗
• InjuryJun 20, 2019Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "MECHANICAL FAILURE OF RIGHT TOTAL KNEE ARTHROPLASTY".

  Patient problems: Injury

  MAUDE report 8716840 ↗
• InjuryJun 11, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO " FAILED RIGHT TOTAL KNEE ARTHROPLASTY FOR INSTABILITY."

  Patient problems: Injury

  MAUDE report 8687091 ↗
• InjuryMay 1, 2019Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LAXITY TO RIGHT TOTAL KNEE." *UPDATE ON 27-AUG-2021: THIS PI IS FOR REVISION SURGERY IN 2013. "[...] ON (B)(6) 2013 WITH A PREOPERATIVE DIAGNOSIS OF LAXITY TO RIGHT TOTAL KNEE. THE PROCEDURE WAS A REVISION OF THE POLYETHYLENE INSERT. SURGEON REMOVED THE 9 MM INSERT AND PUT IN AN 11 MM. "

  Patient problems: Injury; Joint Laxity; Pain

  MAUDE report 8568511 ↗
• InjuryJan 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A PRIMARY AND REVISION IMPLANT SHEET THAT PATIENT'S RIGHT KNEE WAS REVISED. A TRIATHLON CS CONSTRUCT (BASEPLATE, FEMORAL COMPONENT, INSERT) WAS REVISED TO A 9 DEVICE TS CONSTRUCT INCLUDING STEMS, AUGMENTS, ADAPTER, AND A PATELLA.

  Patient problems: Injury

  MAUDE report 8250713 ↗
• InjuryJan 10, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION CONTRACTURE (COULD NOT BEND HER KNEE DUE TO SOFT TISSUE IMPINGEMENT). A SIZE 4 TRIATHLON CR FEMORAL COMPONENT AND SIZE 4 TRIATHLON CS INSERT WERE REVISED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8235960 ↗
• MalfunctionDec 21, 2018Packaging Problem; Packaging Problem

  DURING SURGERY, THE NURSE WAS OPENING THE IMPLANTS AND NOTICED THE INNER PLASTIC BOX OF THE FEMORAL IMPLANT (B)(4) WAS DAMAGED AND THEREFORE QUESTIONED THE STERILITY. ANOTHER IMPLANT FROM CONSIGNMENT STOCK WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8190262 ↗
• MalfunctionNov 13, 2018Contamination; Contamination

  PRIMARY PROCEDURE, RIGHT KNEE. IT AS REPORTED THAT WHEN THE DEVICE WAS OPENED IN THE FIELD, WHITE PARTICULATE MATTER WAS SEEN ON THE DEVICE. CEMENT WAS USED DURING THE PROCEDURE BUT HAD NOT BEEN OPENED AT TIME OF DISCOVERY. A SECOND DEVICE WAS OBTAINED FROM HOSPITAL INVENTORY AND USED TO COMPLETE THE PROCEDURE. REP REPORTED A SURGICAL DELAY OF APPROXIMATELY 5 MINUTES WITH NO TOURNIQUET USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8064620 ↗