Triathlon 5510-F-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07613327040302), received between Oct 18, 2018 and Jun 27, 2025 — classified as 33 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unstable” (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 36 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2025Unstable; Unstable

  AS REPORTED: "REV R TKA FEMORAL REVISION FOR INSTABILITY." A SIZE 5 RIGHT CEMENTED CR FEMUR AND 4X10 CS INSERT WERE REVISED TO A SIZE 5 RIGHT TS FEMUR WITH STEM, EXTENDER AND AUGMENTS, AND A 4X11 TS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 22349800 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE. THE PATIENT HAD AN INFECTION IN THIS KNEE PRIOR TO THE INDEX SURGERY. DUE TO THE INFECTION THE IMPLANTS IN THE INDEX CASE WERE LOOSELY CEMENTED WITH THE INTENT OF CLEARING THE INFECTION AND BEING REVISED TO DEFINITIVE IMPLANTS. A STEM WAS ADDED TO THE TIBIAL COMPONENT TO ADD STABILITY TO THIS CONSTRUCT. SUBSEQUENTLY THE PATIENT FELL AND FRACTURED THEIR DISTAL FEMUR. THE REVISION TODAY WAS PERFORMED TO ADDRESS THE FRACTURE. PREOP CULTURES WERE NEGATIVE FOR INFECTION. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Bone Fracture(s)

  MAUDE report 21343165 ↗
• InjuryOct 22, 2024Use of Device Problem; Use of Device Problem

  AS REPORTED: "INCORRECT IMPLANT WAS OPENED AND IMPLANTED. PATIENT WAS BROUGHT BACK INTO ROOM TO REVISE WITH CORRECT PRESSFIT IMPLANT." CLARIFICATION FROM MPS: ORIGINAL PROCEDURE COMPLETED 'NORMALLY' (NO PROBLEMS YET PERCEIVED); PATIENT WHEELED OUT OF O.R. DISCOVERY MADE. PATIENT WAS WHEELED BACK, REVISION PROCEDURE COMPLETED NORMALLY. NO INTRA-OP DELAYS. TIME BETWEEN ORIGINAL SURGERY AND REVISION WAS 45 MINUTES. RT LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20503560 ↗
• InjuryJun 13, 2024Unstable; 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 WITH STEM AND TS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 19528700 ↗
• InjuryMar 2, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO RANGE OF MOTION ISSUES. A CR FEMUR AND CS INSERT WERE REVISED TO A PS FEMUR WITH TS INSERT. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 18823369 ↗
• InjuryFeb 15, 2024Use of Device Problem; Use of Device Problem

  PRIMARY PROCEDURE, RIGHT KNEE. KNEE WAS PLANNED FOR SIZE 5 RIGHT PRESSFIT CR FEMUR. A SIZE 5 RIGHT CEMENTED CR FEMUR WAS IMPLANTED. SURGEON WAS NOTIFIED POST-OP. PATIENT HAD LEFT OR, WAS NOTIFIED AND RETURNED FOR REVISION OF THE CEMENTED FEMUR FOR THE PRESSFIT FEMUR THE NEXT DAY.

  Patient problems: Insufficient Information

  MAUDE report 18710885 ↗
• InjuryJul 20, 2023Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPORTED: "I COVERED A REVISION KNEE SURGERY TODAY THAT HAD A CEMENTED FEMUR IMPLANTED AS A PRESSFIT FEMUR. I WAS NOT THE REP FOR THE ORIGINAL SURGERY. I DON'T HAVE ANY OF THE IMPLANTS FROM THE SURGERY." SPOKE TO REP. PATIENT'S RIGHT KNEE WAS REVISED AFTER COMPLAINT OF PAIN, INTRA-OPERATIVELY, IT WAS DISCOVERED THAT A CEMENTED FEMUR HAD BEEN IMPLANTED WITHOUT CEMENT IN (B)(6) 2023 DURING A MAKO TKA. FEMORAL COMPONENT AND INSERT WERE REVISED. REP PROVIDED PRIMARY USAGE, AND CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 17368420 ↗
• InjuryJun 12, 2023Use of Device Problem; Use of Device Problem

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT 1 DAY POST-OP, DISCOVERY WAS MADE THAT A CEMENTED FEMUR WAS IMPLANTED WHEN A PRESS-FIT FEMUR WAS PLANNED. SURGEON WAS NOTIFIED AND PLANS TO REVISE TO A PRESS-FIT FEMUR ON (B)(6) 2023. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 23 MAY 23 MA: REVISION COMPLETED ON (B)(6) 2023 "THERE WERE NO COMPLICATIONS."

  Patient problems: Insufficient Information

  MAUDE report 17103117 ↗
• InjuryMay 30, 2023Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPORTED BY THE KEY ACCOUNTS MANAGER, WHO WAS NOT PRESENT FOR THE SURGERY: PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT A CEMENTED FEMORAL COMPONENT WAS IMPLANTED WHEN A PRESS-FIT IMPLANT WAS INTENDED. ADDITIONAL INFORMATION PROVIDED BY THE MANAGER: SURGEON'S PROTOCOL IS TO IMPLANT A 'HYBRID' KNEE CONSTRUCT WITH A CEMENTED TIBIA AND PRESS-FIT FEMUR. MPS COVERING THE CASE WAS NOT FAMILIAR WITH THE SURGEON OR THE SURGEON'S PROTOCOL AND SHOWED CEMENTED COMPONENTS TO THE SURGEON (WITH THEIR ASSUMPTION THAT ALL COMPONENTS WOULD BE CEMENTED). SURGEON APPROVED THE IMPLANTS (WITH HIS ASSUMPTION THAT THE TIBIA WOULD BE CEMENTED AND THE FEMUR WOULD BE PRESS-FIT). THE CEMENTED FEMORAL COMPONENT WAS IMPLANTED WITHOUT CEMENT. REALIZATION WAS MADE POST-OP AND THE PATIENT'S FEMORAL COMPONENT WAS REVISED THE SAME DAY TO A PRESS-FIT FEMORAL COMPONENT. MANAGER CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 17020728 ↗
• InjuryMay 30, 2023Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPORTED BY THE KEY ACCOUNTS MANAGER, WHO WAS NOT PRESENT FOR THE SURGERY: PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT A CEMENTED FEMORAL COMPONENT WAS IMPLANTED WHEN A PRESS-FIT IMPLANT WAS INTENDED. ADDITIONAL INFORMATION PROVIDED BY THE MANAGER: SURGEON'S PROTOCOL IS TO IMPLANT A 'HYBRID' KNEE CONSTRUCT WITH A CEMENTED TIBIA AND PRESS-FIT FEMUR. MPS COVERING THE CASE WAS NOT FAMILIAR WITH THE SURGEON OR THE SURGEON'S PROTOCOL AND SHOWED CEMENTED COMPONENTS TO THE SURGEON (WITH THEIR ASSUMPTION THAT ALL COMPONENTS WOULD BE CEMENTED). SURGEON APPROVED THE IMPLANTS (WITH HIS ASSUMPTION THAT THE TIBIA WOULD BE CEMENTED AND THE FEMUR WOULD BE PRESS-FIT). THE CEMENTED FEMORAL COMPONENT WAS IMPLANTED WITHOUT CEMENT. REALIZATION WAS MADE POST-OP AND THE PATIENT'S FEMORAL COMPONENT WAS REVISED THE SAME DAY TO A PRESS-FIT FEMORAL COMPONENT. MANAGER CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 17020726 ↗
• InjuryOct 28, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO A CEMENTED FEMORAL COMPONENT HAVING BEEN IMPLANTED IN A KNEE PREPPED FOR PRESS-FIT. REPORTING REP WAS NOT PRESENT FOR THE INDEX PROCEDURE. REP CONFIRMED THAT HE MAY BE ABLE TO SUPPLY SOME PATIENT DETAILS, DATE OF IMPLANT, AND IMPLANT DETAILS. OTHERWISE, THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15694233 ↗
• InjuryJul 19, 2022Osseointegration Problem; Osseointegration Problem

  PLEASE FIND INFORMATION FROM A REVISION OF RIGHT TOTAL KNEE DONE TODAY. REVISION WAS DONE DUE TO LOOSE PAINFUL FEMORAL COMPONENT. PHOTOS ARE OF IMPLANTS THAT WERE REMOVED, THE SIZE 5 UNIVERSAL BASEPLATE WAS NOT REVISED, NO OTHER INFORMATION ON PREVIOUS SURGERY AVAILABLE. NO FURTHER INFORMATION AVAILABLE FROM DOCTOR OR HOSPITAL.

  Patient problems: Pain

  MAUDE report 15050858 ↗
• InjuryJan 14, 2022Unstable; Unstable

  RIGHT KNEE REVISED FOR INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 13257868 ↗
• InjuryNov 15, 2021Use of Device Problem; Use of Device Problem

  PRIMARY RIGHT MAKO KNEE. POST-OPERATIVELY, IT WAS DISCOVERED THAT A CEMENTED FEMORAL COMPONENT WAS PUT INTO A KNEE PLANNED FOR A PRESS-FIT FEMORAL COMPONENT. SURGEON WAS NOTIFIED AND 1 DAY POST-OP, THE COMPONENT WAS REMOVED AND A CEMENTED FEMORAL COMPONENT WAS CEMENTED IN. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE PACKAGE LABELING OR THE PACKAGE CONTENTS OF THE ORIGINAL IMPLANT. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12814345 ↗
• InjuryApr 9, 2021Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. PRE-OPERATIVELY, THE SURGEON SUSPECTED THE CAUSE OF PAIN TO BE FEMORAL LOOSENING AND OSTEOLYSIS DUE TO POLY WEAR, DUE TO LUCENCY SEEN ON X-RAY. INTRA-OPERATIVELY, THOUGH NOTED TO NOT BE GROSSLY LOOSE, THE EXISTENCE OR DEGREE OF LOOSENESS OF THE CEMENTED FEMORAL COMPONENT WAS NOT REPORTED TO THE REP. THE POLY HAD NO VISIBLE WEAR. REP IS REQUESTING INVESTIGATION RESULTS ON THE INSERT, WHICH IS ALLEGEDLY BEING RETURNED. PATIENT WAS REVISED TO A SIZE 4 PS FEMUR WITH A 5X10 INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11642743 ↗
• InjuryNov 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION THAT THE PATIENT'S RIGHT KNEE WAS REVISED. A SIZE 5 RIGHT CR FEMUR AND 5X9 CS INSERT WERE REVISED TO A SIZE 6 RIGHT TS FEMUR WITH A STEM AND 4 AUGMENTS AND A 5X13 PS INSERT.

  Patient problems: Insufficient Information

  MAUDE report 10779501 ↗
• InjuryOct 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION CONTRACTURE. THE PATIENT'S CR KNEE WAS REVISED TO AN MRH KNEE (PATELLAR COMPONENT WAS RETAINED). REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 10654378 ↗
• InjuryJun 29, 2020Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  INFORMATION RECEIVED IN FOLLOW-UP INCLUDES AN OPERATIVE REPORT FOR A RIGHT KNEE REVISION ON (B)(6) 2018. NOTED IN THE RECORDS ARE THE FOLLOWING: "HAD A FALL. SHE IS NOW HAVING SYMPTOMS OF PAIN AND PRESENTED TODAY FOR OPERATIVE INTERVENTION FAILED RIGHT KNEE ARTHROPLASTY WITH PATELLAR LOOSENING, INSTABILITY, AND EXTENSOR MECHANISM COMPROMISE. THE PATIENT'S PATELLAR COMPONENT WAS GROSSLY LOOSE AND FREE-FLOATING." A CR FEMUR, CS INSERT, AND TRIATHLON PATELLA WERE REVISED TO A TS FEMORAL COMPONENT WITH A STEM AND 4 AUGMENTS, A PS INSERT, AND A COMPETITOR PATELLA.

  Patient problems: Fall; Injury; Pain

  MAUDE report 10206338 ↗
• InjuryNov 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI WAS RAISED FROM A MEDICAL REVIEW FOR PI. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2016 FOR A PERIPROSTHETIC FRACTURE OF THE FEMUR. NO COMPONENTS WERE EXPLANTED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9285957 ↗
• MalfunctionSep 9, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A TRIATHLON IMPLANT TRIATHLON-CR FEM CEMENT #5 RT WHICH WAS EXPOSED TO WATER AND STEAM AT (B)(6) HOSPITAL, WAS REDISTRIBUTED BY STRYKER (B)(4) AND SUBSEQUENTLY IMPLANTED DURING A PROCEDURE AT (B)(6) HOSPITAL. A FULL LOAN TRIATHLON IMPLANT SET WAS ACCIDENTALLY RETRIEVED FROM A HOSPITAL BY A COURIER AND WAS RETURNED TO A STRYKER KIT ROOM. HOWEVER, THE COURIER WAS UNAWARE THAT THE ITEMS WERE AFFECTED AND THEREFORE DID NOT COMMUNICATE TO THE KIT ROOM THAT THESE PARTS WERE PREVIOUSLY QUARANTINED AT THE HOSPITAL. AS A RESULT THE KIT ROOM DID NOT PROCEED WITH ANY QUARANTINE ACTION AND 18 OF THE AFFECTED ITEMS WERE RE-DISTRIBUTED. UPDATE 19/AUGUST/2019 WG: NONE OF THE PACKAGING WAS RETAINED FROM THE IMPLANTED DEVICES. SURGEONS EXPRESSED NO CONCERN, AND HAVE COMMUNICATED NO PLANS TO SURGICALLY ADDRESS THE IMPLANTATION OF THE DEVICES. TO DATE, NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED FOR THESE PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974367 ↗
• InjuryAug 9, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO RIGHT KNEE CORONAL PLANE INSTABILITY.

  Patient problems: Injury

  MAUDE report 8879891 ↗
• InjuryAug 9, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO FAILED RIGHT TOTAL KNEE ARTHROPLASTY, MECHANICAL LOOSENING OF COMPONENTS.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8879406 ↗
• InjuryAug 9, 2019Unstable; Unstable

  THIS PI IS FOR THE RIGHT KNEE. IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO RIGHT AND LEFT KNEE POSTOPERATIVE TOTAL KNEE ARTHROPLASTY WITH INSTABILITY.

  Patient problems: Injury

  MAUDE report 8878771 ↗
• InjuryMay 28, 2019Unstable; Unstable

  DR. REVISED PATIENT'S FEMORAL COMPONENT DUE TO FLEXION INSTABILITY. CONVERTED TO A TRIATHLON TS FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 8646621 ↗
• InjuryMay 7, 2019Osseointegration Problem; Osseointegration Problem

  PATIENT'S DAUGHTER STATED HER MOTHER HAD A RIGHT KNEE REPLACEMENT 4 YEARS AGO AND IT RECENTLY FAILED. PATIENT IS EXPERIENCING PAIN. PATIENT IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2018 TO COMPETITIVE DEVICES. REASON FOR REVISION IS LOOSENING. PATIENT WILL ALSO LIKE TO KNOW IF HER IMPLANT WERE PART OF A RECALL.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8588483 ↗