Triathlon 5517-F-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327040937), received between Feb 23, 2017 and Aug 11, 2025 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22776379 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FEMORAL REVISION OF CEMENTLESS CR COMPONENT. SURGEON STATES REASON FOR FEMORAL REVISION IS ARTHROFIBROSIS HOWEVER THE PICTURE OF THE X-RAY SHOWS A POSSIBLE DEEP DISTAL RESECTION (IMPLANT NOT IN CONTACT COMPLETELY WITH BONE). THE PRIMARY REPLACEMENT WAS COMPLETED WITH MAKO ON THE (B)(6) 2024.

  Patient problems: Arthrofibrosis; Inadequate Osseointegration; Scar Tissue

  MAUDE report 22140264 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PLEASE FIND INFORMATION FROM INDEX AND REVISION SURGERIES OF A LEFT TOTAL KNEE. THE REVISION WAS SECONDARY TO MCL RUPTURE. IT IS NOT KNOWN WHEN OR HOW THE MCL RUPTURED. IT IS NOT THOUGHT THAT THE USE OF MAKO DURING THE INDEX PROCEDURE CONTRIBUTED TO THIS FAILURE. NO FURTHER INFORMATION IS AVAILABLE FROM THE SURGEON OR HOSPITAL." A CR/ CS KNEE WAS CONVERTED TO A TRIATHLON HINGE KNEE. PATELLAR COMPONENT WAS NOT REVISED.

  Patient problems: Damage to Ligament(s)

  MAUDE report 22025647 ↗
• InjuryDec 9, 2024Use of Device Problem; Use of Device Problem

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT A CR FEMORAL COMPONENT WAS IMPLANTED IN A KNEE THAT WAS PREPPED FOR A PS FEMUR. ISSUE WAS NOTICED AFTER PATIENT WAS SENT HOME. PATIENT WAS REVISED THE NEXT DAY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 20879721 ↗
• InjurySep 6, 2024Unstable; Unstable

  REVISION OF A LEFT TOTAL KNEE. THE REVISION TODAY WAS PERFORMED SECONDARY TO PAIN AND STIFFNESS. IN SURGERY IT WAS DISCOVERED THAT THE FEMUR WAS NOT INGROWN. THE FEMUR AND INSERT WERE REMOVED. IT WAS DECIDED TO CONVERT TO A PS FEMUR TO ALLOW FOR A BETTER RANGE OF MOTION. THE USE OF MAKO IN THE PRIMARY SURGERY WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS EARLY FAILURE. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Pain

  MAUDE report 20155567 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A LEFT TRIATHLON DUE TO PERIPROSTHETIC FEMUR FRACTURE. HE REVISED TO A DFR AND KEPT THE PATELLA IMPLANT.

  Patient problems: Bone Fracture(s)

  MAUDE report 19785431 ↗
• InjuryJun 6, 2023Loss of Osseointegration; Loss of Osseointegration

  DR. REVISED A TRIATHLON LEFT CEMENTLESS FEMUR AND CS INSERT DUE TO FEMORAL LOOSENING. FELT BONE QUALITY WAS POOR.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17076287 ↗
• InjuryMar 28, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "REVISION TODAY WAS DUE TO INSTABILITY IN EXTENSION. THE USE OF MAKO IN THE INDEX CASE WAS NOT MENTIONED AS A CONTRIBUTOR TO THE INSTABILITY. NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON." A SIZE 4 LEFT CR FEMUR AND 4X9 CS INSERT WERE REVISED TO A SIZE 4 LEFT TS FEMUR WITH STEM AND AUGMENTS, A 4X11 TS INSERT, AND THE PATIENT'S NATIVE PATELLA WAS RESURFACED.

  Patient problems: Joint Laxity

  MAUDE report 16625349 ↗
• InjurySep 9, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THE INSERT AND FEMORAL COMPONENT WERE REVISED. REP SPECIFICALLY CONFIRMED WITH THE SURGEON THAT NO IMPLANTS WERE ALLEGED TO BE LOOSE OR BROKEN. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 15392904 ↗
• InjuryJul 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS ORIGINALLY REPORTED: "WHEN DOING A RIGHT TOTAL KNEE REPLACEMENT...A LEFT FEMORAL KNEE IMPLANT WAS USED INSTEAD OF A RIGHT FEMORAL IMPLANT." SPOKE TO REP, WHO PROVIDED USAGE SHEET. A STRYKER REP WAS PRESENT FOR THE PROCEDURE. DISCOVERY WAS MADE WHEN RECONCILING HOSPITAL INVENTORY. PATIENT IS REPORTED AS ASYMPTOMATIC. TREATMENT PLAN IS TO OBSERVE AND ASSESS THE PATIENT'S PROGRESS, NO PLAN FOR REVISION AS OF THE TIME OF REPORT. REP PROVIDED THE USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OPERATING ROOM SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251798 ↗
• 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: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 12189614 ↗
• InjuryFeb 19, 2021Adverse 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 DUE TO ARTHROFIBROSIS. A SIZE 4 CR FEMORAL COMPONENT AND 5X9 CR INSERT WERE REVISED TO A SIZE 4 TS FEMORAL COMPONENT AND 5X9 CS INSERT WITH A CONE AUGMENT AND CEMENTED STEM. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 11348617 ↗
• InjuryOct 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  REP WAS NOTIFIED THAT THE PATIENT'S ANTERIOR TIBIA COLLAPSED. THE PATIENT HAS NOT YET BEEN REVISED. REVISION DATE IS UNKNOWN AS CASES ARE BEING EVALUATED BEFORE THEY CAN BE PERFORMED. PATIENT ALLEGES THAT THEY EXPERIENCED NO FALLS OR OTHER TRAUMA. UPDATE BASED ON MEDICAL REVIEW: "A REVISION PROCEDURE WAS PERFORMED (B)(6) 2020" & "AS NOTED, THE UNDATED PRE-REVISION X-RAYS (BILATERAL AP/LEFT LATERAL) SHOWED COLLAPSE OF THE TIBIAL COMPONENT AND THE CONCOMITANT TIBIAL PLATEAU (BONE) FRACTURE (ANTERIOR AND MEDIAL). " UPDATE BASED ON MEDICAL REVIEW: "THE UNCEMENTED FEMUR WAS REMOVED AND REPLACED WITH A SIMILAR DEVICE." THE REASON FOR REVISION OF THE FEMORAL COMPONENT WAS NOT MENTIONED.

  Patient problems: Limb Fracture; Pain

  MAUDE report 10613166 ↗
• InjurySep 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: PATIENT HAD VISUAL PATELLA TILT WITH PAIN AND NOISE. THE FEMORAL COMPONENT, 4X9 CR INSERT, AND PATELLAR COMPONENT OF THE PATIENT'S LEFT KNEE WERE REVISED.

  Patient problems: Pain

  MAUDE report 10566219 ↗
• InjuryMay 22, 2019Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8631561 ↗
• MalfunctionMar 21, 2018Packaging Problem; Packaging Problem

  WHEN THE IMPLANT WAS OPENED. IT WAS NOTICED THAT THE INTERNAL PACKAGING DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7357602 ↗
• MalfunctionMar 1, 2018Fitting Problem; Fitting Problem

  TRIATHLON PA CORRECT SIZE FEMUR WOULD NOT STAY ON CUT LEFT FEMUR. ACCORDING TO REP, ISSUE WAS RESOLVED BY CEMENTING A FEMORAL COMPONENT. DELAY WAS ONLY IN TIME NEEDED FOR CEMENT TO CURE. DEVICE IS BEING CLEANED AND WILL BE RETURNED BY HOSPITAL PERSONNEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7307432 ↗
• InjuryFeb 1, 2018Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE SURGEON REPORTED VIA THE SALES REP, (B)(6) THAT A FEMALE PATIENT UNDERWENT A REVISION OF THE LEFT KNEE ON (B)(6) 2017 DUE TO A FRACTURED TIBIAL INSERT SIZE 3 9 MM. IT WAS FURTHER REPORTED THAT THE PATIENT HAD EXPERIENCED A TWISTING TRAUMA TO THE KNEE APPROXIMATELY 2 MONTHS PRIOR TO THE REVISION. IT WAS FURTHER REPORTED THAT THE OPERATION BEGAN AS AN EXPLORATORY ENDOSCOPY BUT WAS TRANSFERRED TO AN OPEN PROCEDURE WHEN IT WAS DISCOVERED THAT THE INSERT HAD FRACTURED. IT WAS FURTHER REPORTED THAT THE INSERT WAS REPLACED WITH A SIZE 3 11 MM INSERT AND THAT THE PRIMARY OPERATION TOOK PLACE ON (B)(6) 2016. **UPDATE: THE MEDICAL REVIEW CONCLUDED MALPOSITION OF BOTH THE FEMORAL COMPONENT AND THE BASEPLATE.

  Patient problems: Injury

  MAUDE report 7233630 ↗
• InjuryMay 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  REMOVE FEMORAL IMPLANT AND REPLACE POLY. PATIENT HAD COMPLAINED OF PAIN. CEMENT LESS FEMUR REPLACED WITH CEMENTED FEMUR OF SAME SIZE AND POLY WAS REPLACED WITH ANOTHER.

  Patient problems: Injury; Pain

  MAUDE report 6588418 ↗
• InjuryFeb 23, 2017Mechanical Problem; Loss of Osseointegration; Defective Device; Device Operates Differently Than Expected; Mechanical Problem; Loss of Osseointegration

  THE CUSTOMER REPORTED THAT THEY REVISED AN UNCEMENTED TRIATHLON KNEE AFTER 3 MONTHS. INFECTION WAS SUSPECTED GIVEN THE EARLY FAILURE, AS THERE IS RADIOLUCENT LINES ON THE FEMORAL SIDE. HOWEVER, THE SURGEON HAS SO FAR RULED OUT INFECTION AS THE CAUSE OF FAILURE, GIVEN ALL BLOOD TESTING, ASPIRATE AND CULTURES ARE NEGATIVE & IS ALLEGING THAT THE REVISION IS DUE TO IMPLANT DEFICIENCIES.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Injury; Osteolysis

  MAUDE report 6354544 ↗