Triathlon 5517-F-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327040944), received between Nov 8, 2017 and Feb 9, 2026 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE. A CR FEMUR AND INSERT WERE REVISED TO A TS FEMUR AND INSERT WITH STEM AND AUGMENTS. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Periprosthetic fracture

  MAUDE report 24298352 ↗
• InjuryMay 7, 2025Improper or Incorrect Procedure or Method; Device Handling Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  THIS REPORT IS FOR CASE 2 OF 2. AS REPORTED BY THE CHIEF NURSING EXECUTIVE OFFICER: TWICE NOW [STRYKER REP] HAS PROVIDED THE PHYSICIAN WITH THE WRONG IMPLANT. THE IMPLANT HAS BEEN COMPLETELY INSERTED AND THE PHYSICIAN HAS CLOSED BEFORE [STRYKER REP] REALIZED HE PROVIDED THE WRONG PRODUCT REQUIRING US TO OPEN THE PATIENT A SECOND TIME. RIGHT TKA; DOCTOR WAS CLOSING WHEN NOTICED, PATIENT NEVER LEFT ROOM AND FEMUR WAS TAKEN OUT AND CORRECT FEMUR WAS PUT IN.

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

  MAUDE report 21975601 ↗
• InjuryMay 7, 2024Material Erosion; Unstable; Material Erosion; Unstable

  PATIENT CAME BACK DUE TO KNEE PAIN. CASE WENT SMOOTH, ISSUE IS THE POLY HAS WORN OUT ON THE MEDIAL SIDE IN A FEW YEARS. WE ARE REVISING THIS IN TWO WEEKS. THE POSTERIOR MEDIAL SIDE OF POLY WAS WORN DOWN AND HAD A SMALL CRACK. THE FEMUR HAD A SMALL SIGN OF RUBBING RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19265708 ↗
• InjuryMay 3, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LIGAMENT LAXITY. A 3X9 CS INSERT AND SIZE 4 PRESSFIT CR FEMUR WERE REVISED TO A SIZE 4 PS FEMUR AND 3X11 PS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 19236419 ↗
• InjuryFeb 27, 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 18789942 ↗
• InjuryFeb 14, 2024Mechanical Problem; Mechanical Problem

  RIGHT TOTAL KNEE. THE REVISION TODAY WAS, DUE TO STIFFNESS AND ¿CATCHING¿ IN THE KNEE. IT WAS DECIDED, THAT A PS KNEE ADDED STABILITY AND RANGE OF MOTION. MAKO WAS NOT MENTIONED AS CONTRIBUTING TO THIS COMPLICATION.

  Patient problems: Loss of Range of Motion

  MAUDE report 18704546 ↗
• InjuryMay 17, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PATIENT COMPLAINT OF LIMITED ROM (SURGEON REPORTED THAT PATIENT HAD NOT PARTICIPATED IN PT POST-OP). INTRA-OPERATIVELY, THE POSTERIOR CONDYLES OF THE FEMORAL COMPONENT WERE FOUND TO NOT BE INGROWN. THE PRESSFIT FEMORAL COMPONENT WAS REVISED TO A CEMENTED FEMORAL COMPONENT, AND A 5X10 CS INSERT WAS REVISED TO A 5X9 CS INSERT.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16944297 ↗
• InjuryApr 28, 2022Malposition of Device; Unintended Movement; Malposition of Device; Unintended Movement

  AS REPORTED: "REVISION OF RIGHT FEMUR." A FEMORAL COMPONENT AND INSERT WERE REVISED. UPDATE (B)(6) 2022: THE REVISED THAT WAS ON (B)(6) 2022. THE FIRST SURGERY WAS DONE ABOUT MONTH AND HALF BEFORE. FEMORAL COMPONENT WAS REMOVED DUE TO ITS MAL-PLACEMENT. PT COMPLAINING OF PAIN.

  Patient problems: Pain

  MAUDE report 14237692 ↗
• InjuryNov 11, 2021Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BILATERAL STAGED INDEX TKA. PATIENT COMPLAINS OF INSTABILITY AND VALGUS DEFORMITY. RIGHT LATERAL PLATEAU COLLAPSE. UNDERGOES REVISION ON (B)(6) 2021. ALL COMPONENTS EXCHANGED EXCEPT PATELLA.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12795163 ↗
• InjuryAug 16, 2021Unstable; Unstable

  AS REPORTED: "PAIN AND INSTABILITY. ALL AVAILABLE INFORMATION SUBMITTED." THE PATIENT'S RIGHT KNEE WAS REVISED. A 3X9 CR INSERT, SIZE 4 CR FEMORAL COMPOENT, AND SIZE 3 TRITANIUM BASEPLATE WERE REVISED TO A TS FEMORAL COMPONENT, PS INSERT, AND NEW BASEPLATE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12323564 ↗
• InjuryMay 24, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER COMPLAINT OF INSTABILITY AND DISLOCATION. INITIALLY, SURGEON PLANNED TO DO A POLY EXCHANGE DUE TO POSTERIOR WEAR OF THE POLY. HOWEVER, BECAUSE THE PATIENT CONTINUED TO WALK ON THE KNEE FOR MONTHS, THE POLY WORE THROUGH, THE TIBIAL BASEPLATE BECAME DAMAGED, AND THE FEMORAL COMPONENT BECAUSE SCRATCHED UP. SIGNIFICANT METAL DEBRIS WAS NOTED INTRA-OPERATIVELY. THE FEMORAL COMPONENT, INSERT, AND BASEPLATE WERE REVISED. REP CONFIRMED HE CAN PROVIDE SOME PICTURES, AND THAT OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11869255 ↗
• 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 11140694 ↗
• 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 11043062 ↗
• InjuryMar 26, 2020Off-Label Use; Misassembly by Users; Off-Label Use; Misassembly by Users

  IT WAS REPORTED THAT THE PATIENT'S RIGHT MAKO TKA WAS REVISED DUE TO IMPLANTATION OF A CR FEMUR IN A KNEE PREPPED FOR PS. REP WAS NOT PRESENT FOR THE PROCEDURE. INTRA-OPERATIVELY, THE FEMUR WAS PREPPED AND TRAILED FOR A PS IMPLANT. AFTER THE MPS WOULD HAVE BROUGHT THE IMPLANT TO THE OR PRIOR TO THE PROCEDURE, THE DEVICE WOULD HAVE BEEN SHOWN TO THE CIRCULATING NURSE, THEN TO THE SURGICAL TECH, AND SHOWN AND HANDED TO THE SURGEON OR SURGEON'S PA. UPON BILLING OF THE CASE, THE FACT THAT THE CR FEMUR WAS IMPLANTED WAS BROUGHT TO THE SURGEON'S ATTENTION. THE SURGEON TOOK X-RAYS ON (B)(6) 2020 AND CONFIRMED A CR FEMUR WAS IN THE PATIENT. THE PATIENT WAS THEN REVISED. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9885061 ↗
• InjuryAug 13, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THE DOCTOR REVISED A TRIATHLON CR CEMENTLESS FEMUR DUE TO BONE COLLAPSE/IMPLANT SUBSIDENCE. HE REVISED TO A PS FEMUR WITH A 10MM DISTAL AUGMENT AND A PS INSERT. UPDATE (B)(6) 2019 WG: REP PROVIDED THE PRIMARY TKA OPERATIVE REPORT, PRE-REVISION X-RAYS, AND USAGE SHEETS FROM THE PRIMARY AND REVISION PROCEDURES AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8889024 ↗
• InjuryMay 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A RUPTURED PCL. POSSIBLE CAUSE OR CONTRIBUTOR FOR THE RUPTURE WAS NOT REPORTED TO THE REP BUT THERE ARE NO ALLEGATIONS AGAINST THE STRYKER CONSTRUCT. THE LINER AND FEMORAL COMPONENT WERE REVISED TO TS COMPONENTS. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8616966 ↗
• InjuryFeb 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. UPDATE (B)(6) 2019: CORRECTION TO THE ABOVE, REVISION WAS FOR PATIENT'S RIGHT KNEE AS PER REVISION IMPLANT SHEET ON (B)(6) 2019. A SIZE 4 RIGHT CR FEMUR AND 4X11 CS INSERT WAS REVISED TO A SIZE 3 RIGHT TS FEMUR WITH 12X50 STEM AND A 4X9 PS INSERT.

  Patient problems: Injury

  MAUDE report 8369951 ↗
• InjuryFeb 12, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A SIZE 4 CR FEMUR AND 3X16 CS INSERT WERE REVISED TO A SIZE 4 TS FEMUR WITH STEM AND AUGMENTS, AND 3X16 TS INSERT.

  Patient problems: Injury

  MAUDE report 8333180 ↗
• InjuryJul 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD RIGHT KNEE SURGERY DONE ON (B)(6) 2013 AND WAS REVISED ON (B)(6) 2018 DUE TO LITTLE BONE GROWTH. PATIENT WAS REVISED TO NON STRYKER IMPLANTS.

  Patient problems: Injury

  MAUDE report 7654913 ↗
• InjuryApr 9, 2018Malposition of Device; Malposition of Device

  PATIENT VISIT OUT CLINIC WITH PAIN AND INSTABILITY. UPDATE: BASED ON THE MEDICAL REVIEW - FEMORAL COMPONENT MALPOSITION IN POSTERIOR POSITION PLUS EXCESSIVE DISTAL FEMORAL BONE RESECTION IN COMBINATION WITH BASEPLATE MALPOSITION IN EXCESSIVE POSTERIOR SLOPE OF 11° HAS CONTRIBUTED TO COMPLEX AND GLOBAL KNEE INSTABILITY WITH PAIN SYMPTOMS REQUIRING REVISION.

  Patient problems: Injury; Pain

  MAUDE report 7406183 ↗
• MalfunctionNov 22, 2017Packaging Problem; Packaging Problem

  A DISTRIBUTOR REPORTED THAT: "BEFORE THE SURGERY, WHEN PREPARING THE DEVICES, THE MEDICAL STAFF OBSERVED THAT THE PACKAGING WAS NOT DAMAGED BUT THE INNER PLASTIC SHELL IS BROKEN AT THE WELD. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7054256 ↗
• MalfunctionNov 8, 2017Fitting Problem; Scratched Material; Fitting Problem; Scratched Material

  SURGEON WAS PERFORMING A RIGHT MAKO TOTAL KNEE ON A (B)(6) YEAR OLD WOMAN. SURGEON MADE ALL HIS KNEE CUTS ACCORDING TO PLAN AND DECIDED HE WANTED TO PRESS FIT THE FEMORAL AND TIBIAL COMPONENTS AND CEMENT THE PATELLA. SURGEON IMPACTED A TRIATHLON TRITANIUM PRESS FIT TIBIAL BASEPLATE ONTO THE TIBIA WITHOUT ANY ISSUE. HE THEN PROCEEDED TO IMPACT A SIZE 4 RIGHT PRESS FIT TRIATHLON CR FEMUR ONTO THE PATIENT'S FEMUR. AFTER HIS IMPACTION OF THE FEMUR, THE SURGEON BROUGHT TO OUR ATTENTION THAT THE FEMORAL COMPONENT WAS LOOSE AND NOT IDEAL FOR PRESS FITTING. AT THIS POINT, THE SURGEON REMOVED THE PRESS FIT FEMORAL COMPONENT AND MOVED FORWARD WITH A #4 RIGHT CR CEMENTED FEMORAL COMPONENT. THIS FEMORAL COMPONENT WAS SUCCESSFULLY IMPACTED ONTO THE FEMUR AND HE PROCEEDED TO CEMENT THE PATELLA. ONCE THE CEMENT WAS DRY AN INSERT WAS IMPLANTED AND THE KNEE WAS CLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011833 ↗