Triathlon 5532-G-509Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 07613327050776), received between Aug 7, 2017 and Jul 18, 2025 — classified as 34 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT AN MUA WAS PERFORMED ON THE PATIENT'S RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22546408 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT AN MUA WAS PERFORMED ON THE PATIENT'S LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22477619 ↗
• InjuryDec 6, 2024Mechanical Problem; Mechanical Problem

  THIS PI IS FOR THE MUA. SUBJECT HAD REVISION OF COMPETITOR COMPONENTS ON (B)(6) 2018 WITH STRYKER CONE AUGMENTS AND IS ENROLLED IN THE 76 - TRIATHLON CONES STUDY. SUBJECT REQUIRED A MANIPULATION UNDER ANESTHESIA FOR DECREASED/LIMITED ROM WHICH APPEARS MAY BE ONGOING.

  Patient problems: Loss of Range of Motion

  MAUDE report 20863165 ↗
• InjuryDec 6, 2024Mechanical Problem; Mechanical Problem

  THIS PI IS FOR THE ONGOING ISSUES AFTER MUA. SUBJECT HAD REVISION OF COMPETITOR COMPONENTS ON (B)(6) 2018 WITH STRYKER CONE AUGMENTS AND IS ENROLLED IN THE 76 - TRIATHLON CONES STUDY. SUBJECT REQUIRED A MANIPULATION UNDER ANESTHESIA FOR DECREASED/LIMITED ROM WHICH APPEARS MAY BE ONGOING (OFFICE NOTE ALSO INDICATES PATIENT IS HAVING ISSUES WITH PAIN, 7/10). INSTABILITY AS WELL.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20863162 ↗
• MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PREPARATION OF IMPLANTS FOR IMPLANTATION, DAMAGE TO THE BRAND NEW PRODUCT WAS FOUND. FOLLOWING THE INCIDENT, THE IMPLANT WAS REPLACED WITH A NEW ONE OF THE SAME SIZE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT ANY DELAYS.

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

  MAUDE report 19151166 ↗
• InjurySep 5, 2022Unstable; Migration; Unstable; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO TIBIAL SUBSIDENCE AND INSTABILITY. AS THE TIBIAL BASEPLATE WAS DEEMED TO BE INGROWN, IT WAS LEFT IN SITU AND A 5X9 INSERT WAS REVISED TO A 5X12 INSERT.

  Patient problems: Joint Laxity

  MAUDE report 15355529 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "PAIN INCREASING AS OF 1 YEAR AGO, WORSE OVER THE PAST 6 MONTHS. SUBJECT HAS BECOME MORE PERSONALLY ACTIVE. WAS HAPPY WITH THE RESULTS UNTIL ABOUT 6 MONTHS, 1 YEAR AGO AS PAIN HAS INCREASED."

  Patient problems: Pain

  MAUDE report 14186942 ↗
• InjuryApr 22, 2022Unstable; Unstable

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "PAIN AFTER SITTING FOR LONG PERIOD AND NIGHT PAIN. DISAPPOINTED WITH PAIN AND FEELS LOOSE."

  Patient problems: Joint Laxity; Pain

  MAUDE report 14186940 ↗
• InjuryApr 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "PAIN ALL THE TIME, ESPECIALLY AT NIGHT."

  Patient problems: Pain

  MAUDE report 14186638 ↗
• InjuryOct 25, 2021Adverse 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 DUE TO JOINT LAXITY. A 5X9 PS INSERT WAS REVISED TO A 5X13 TS INSERT.

  Patient problems: Joint Laxity

  MAUDE report 12689518 ↗
• InjuryAug 11, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. PATIENT REPORTED HE HAD BEEN KNEELING OR SQUATTING AND FELT THE KNEE GIVE. INTRA-OPERATIVELY, THE POST OF THE PS INSERT WAS FOUND TO HAVE BROKEN. THE INSERT WAS EXCHANGED. REP HAS THE DEVICE AVAILABLE FOR RETURN AND CAN PROVIDE PICTURES. REP CONFIRMED THE SURGEON WANTS INVESTIGATION RESULTS, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12306309 ↗
• InjuryApr 26, 2021Unstable; Unstable

  PATIENT WOULD LIKE TO KNOW IF HER IMPLANT ARE PART OF A RECALL. PATIENT IS ASYMPTOMATIC. UPDATED ON 01APR2021 BASED ON MEDICAL REVIEW: "UNTIL (B)(6) 2020 ON THE LEFT THE ROM WAS 0-90°, ALSO WITH 1MM OPENING TO VARUS STRESS AND STABLE TO VALGUS STRESS. THERE WAS A MILD INFUSION AND GOOD STRENGTH."

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 11724092 ↗
• InjuryJan 19, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE POST OF THE PS INSERT BEING SHEARED OFF. A 5X9 PS INSERT WAS REVISED TO A 5X9 TS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11191937 ↗
• InjuryJan 11, 2021Unstable; Unstable

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. NOTED ON THE SHEET: "REASON: KNEE PAIN, INSTABILITY." A 5X9 PS INSERT AND A29 PATELLA WERE REVISED TO A 5X11 PS INSERT AND A32 PATELLA. SALES BRANCH PROVIDED PRIMARY AND REVISION USAGE SHEETS. SPOKE TO REP, WHO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11152220 ↗
• InjuryOct 19, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THE SURGEON'S INITIAL PLAN WAS TO EXCHANGE THE POLY. HOWEVER, INTRA-OPERATIVELY SURGEON DECIDED KNEE STABILITY WAS STILL INSUFFICIENT, AND REVISED THE PS FEMUR AND INSERT TO A TS FEMUR AND INSERT WITH A STEM. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Joint Laxity

  MAUDE report 10695925 ↗
• InjuryJul 14, 2020Unstable; Unstable

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO POSSIBLE INSTABILITY. AN 8 MM TRIATHLON TIBIAL BEARING INSERT WAS REVISED TO A 13 MM TRIATHLON TIBIAL BEARING INSERT. SALES BRANCH PROVIDED PRIMARY AND REVISION USAGE SHEETS. REP CONFIRMED THAT NO OTHER INFORMATION IS AVAILABLE DUE TO SEALED ELECTRONIC MEDICAL RECORDS.

  Patient problems: Injury

  MAUDE report 10269826 ↗
• InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION. THE PATIENT'S ENTIRE KNEE CONSTRUCT WAS REMOVED AND A SPACER PLACED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9726794 ↗
• InjuryFeb 3, 2020Unstable; Unstable

  REVISION KNEE WITH POLY EXCHANGE ON (B)(6) 2020. PATIENT PRESENTED TO DR OFFICE FOR UNSTABLE LEFT KNEE. ORIGINALLY HAD DR ON (B)(6) 2017. PUT IN A PRESSFIT TRIATHLON PS LEFT KNEE.

  Patient problems: Injury

  MAUDE report 9659423 ↗
• InjuryAug 9, 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 A FAILED RIGHT TOTAL KNEE ARTHROPLASTY.

  Patient problems: Injury

  MAUDE report 8879238 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2016. PATIENT UNDERWENT RESECTION OF ALL COMPONENTS, AND IMPLANTATION OF A FUNCTIONAL SPACER FOR RIGHT JOINT INFECTION (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8821683 ↗
• InjuryJun 20, 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 "OTHER SPECIFIED COMPLICATION OF INTERNAL PROSTHETIC DEVICES, IMPLANTS NOT ELSEWHERE CLASSIFIED".

  Patient problems: Injury

  MAUDE report 8717590 ↗
• InjuryJun 20, 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 " FAILURE OF TOTAL KNEE ARTHROPLASTY, LEFT KNEE ".

  Patient problems: Injury

  MAUDE report 8716844 ↗
• InjuryMay 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LINER EXCHANGE WAS PERFORMED ON THE PATIENT'S RIGHT KNEE AFTER PATIENT COMPLAINT OF PAIN. ALL OTHER COMPONENTS WERE WELL-FIXED AND WERE NOT REVISED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 8623740 ↗
• InjuryMar 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS EXPERIENCING PATELLA TRACKING ISSUES. THE SURGEON SUSPECTED PATELLA CLUNK SYNDROME. WE DEBRIDED SOFT TISSUE FROM THE JOINT AND EXCHANGED THE 9MM INSERT FOR AN 11MM INSERT; RIGHT SIDE.

  Patient problems: Injury

  MAUDE report 8461354 ↗
• InjuryDec 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DUE TO A DISENGAGED TIBIAL INSERT, IT WAS REMOVED AND REPLACED WITH A NEW ONE.

  Patient problems: Injury

  MAUDE report 8141694 ↗