Triathlon 5531-G-511Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327045864), received between Jan 16, 2017 and Feb 29, 2024 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD LEFT TKA ON (B)(6) 2019. PATIENT DEVELOPED FEMOROPATELLAR ARTHRITIS SINCE THE PATELLA WAS NOT RESURFACED. PATIENT HAD A LEFT TKA REVISION WITH ONLY POLY EXCHANGE AND RESURFACING OF THE PATELLA.

  Patient problems: Arthritis

  MAUDE report 18805653 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRESENTED WITH PAINFUL KNEE ON (B)(6) 2023. PREVIOUS INVESTIGATION FOR INFECTION ON (B)(6) 2021 - NEGATIVE + KNEE SETTLED. CLINICAL TRIAL: RCT COMPARISON OF MECHANICAL AXIS VS FUNCTIONAL ALIGNMENT IN TKA USING MAKO TKA.

  Patient problems: Pain

  MAUDE report 17056905 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LEFT TKA ON (B)(6) 2015. PATIENT PRESENTED WITH PAIN AND SIGNS OF PJI. WAS REVISED ON (B)(6) 2022. ALL COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 15974503 ↗
• InjuryMay 4, 2022Unstable; Unstable

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO GLOBAL INSTABILITY. A 5X11 CS INSERT WAS REVISED TO A 5X16 CS INSERT.

  Patient problems: Insufficient Information

  MAUDE report 14284494 ↗
• InjuryMar 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED WITH LIMITED RANGE-OF-MOTION AND DISCOMFORT OF THE RIGHT-KNEE. DR. PERFORMED AN I&D, EXCISION OF SCAR/FIBROTIC TISSUE WITHIN THE KNEE JOINT, AS WELL AS AN INSERT-SWAP TO HELP WITH ROM. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS THEMSELVES." PATIENT WAS REVISED FROM A 5X11 CS INSERT TO A 5X10 CS INSERT.

  Patient problems: Discomfort; Loss of Range of Motion

  MAUDE report 13677946 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A TRIATHLON INSERT ORIGINALLY DONE (B)(6) 2016 DUE TO SCAR TISSUE REMOVAL AND SOFT TISSUE RELEASES. NO ALLEGATION TOWARDS THE IMPLANTS MADE. ON (B)(6) 2016, DR. (B)(6) CHANGED HIS MIND AFTER FIRST ASKING FOR A 5X9 AND ULTIMATELY WENT WITH A 5X11.

  Patient problems: Insufficient Information

  MAUDE report 13230316 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF RIGHT TRIATHLON PRIMARY TKA. INSERT CHANGED AND PATELLA DONE. SURGEON REPORTED THAT THE REASON FOR REVISION WAS PROGRESSION OF ARTHRITIS.

  Patient problems: Arthritis

  MAUDE report 12127879 ↗
• InjuryFeb 17, 2021Unstable

  PATIENT WITH A TKA COMPLAINED OF INSTABILITY AND PAIN. REVISION TKA WAS PERFORMED AND TIBIAL INSERT WAS CHANGED FROM AN 11MM TO A 13MM INSERT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11339999 ↗
• InjuryNov 3, 2020Unstable; Unstable

  PATIENT HAS INSTABILITY IN HIS RIGHT KNEE. FEMUR APPEARS TO BE ABLE TO SHIFT POSTERIORLY.

  Patient problems: Joint Laxity

  MAUDE report 10779624 ↗
• InjuryOct 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. A SIZE 5 TIBIAL COMPONENT, 5X11 CS INSERT, AND SIZE 5 CR FEMORAL COMPONENT WERE REVISED TO A SIZE 4 PS FEMORAL COMPONENT, 4X16 PS INSERT, SIZE 4 UNIVERSAL BASEPLATE, AND 12X50 STEM. REPORTING REP WAS NOT PRESENT FOR THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 10697510 ↗
• InjuryApr 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "LAXITY LEFT TOTAL KNEE." PATIENT'S 5X11 CS INSERT WAS REVISED.

  Patient problems: Injury

  MAUDE report 9933774 ↗
• InjuryOct 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT 28/SEPTEMBER/2017. PATIENT UNDERWENT TOTAL KNEE REVISION TO TREAT THE DISCOMFORT AND PAIN (B)(6) 2019. FEMORAL COMPONENT AND TIBIAL COMPONENT FIXED WELL, THE PATELLA WAS RESURFACED AND ONLY THE LINER WAS EXCHANGED.

  Patient problems: Injury; Pain

  MAUDE report 9211047 ↗
• InjurySep 23, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A SIZE 5 CR FEMORAL COMPONENT AND 5X11 CS INSERT WERE REVISED TO STRYKER PS DEVICES. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 9105195 ↗
• InjuryAug 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT THE HCP IS CONCERNED OVER A/P INSTABILITY & ANTERIOR SUBLUXATION OF FEMUR USING CS INSERT AFTER THE PRIMARY SURGERY. REFER PHOTO IN INTAKE TAB. PATIENT FUNCTION IS NORMAL. PRIMARY SURGERY: (B)(6) 2019. UPDATE (B)(6) 2019: THIS PI IS FOR THE LEFT KNEE, WHICH HAD A 5X11 CS INSERT. PATIENT HAS NOT BEEN REVISED AS OF THE TIME OF UPDATE.

  Patient problems: Joint Swelling

  MAUDE report 8915177 ↗
• InjuryApr 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A RIGHT KNEE TRIATHLON INSERT FROM A 5X11 CS TO A 5X9 CS DUE TO PATIENT STIFFNESS. ORIGINAL DOS OF THE PRIMARY KNEE WAS DONE (B)(6) 2015.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8565784 ↗
• InjuryOct 30, 2018Unstable; Unstable

  LEFT KNEE REVISION FOR PAIN AND CATCHING. INSERT AND PATELLA REVISED. UPDATE EVENT BASED ON MEDICAL REVIEW RECEIVED: GRADUAL RELAXATION OF REMAINING SCAR TISSUE AFTER A PREVIOUS REVISION FOR ARTHROFIBROSIS IN 2010 WHEN ALSO A THINNER BEARING WAS IMPLANTED RENDERED THE KNEE GRADUALLY UNSTABLE REQUIRING ANOTHER REVISION TO RESTORE KNEE STABILITY TO THE IMMEDIATE POST PRIMARY IMPLANTATION STATE OF 2009.

  Patient problems: Injury; Pain

  MAUDE report 8021685 ↗
• InjurySep 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION OF PATIENT'S LEFT KNEE ON (B)(6) 2018. PATIENT'S LEFT KNEE WAS REVISED AFTER PATIENT FELL, SUSTAINED A DEEP CUT, AND WAS REPORTED TO HAVE INFECTION. A 5 X 11 CS TIBIAL INSERT IMPLANTED WITH A SIZE 4 TIBIAL BASEPLATE WAS REVISED TO A SIZE 4 X 11 PS INSERT. NEITHER THE REP NOR ANYONE ON HIS TEAM WAS PRESENT FOR THE PROCEDURE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Fall; Injury; Unspecified Infection

  MAUDE report 7884976 ↗
• InjuryAug 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISED TOTAL KNEE FOR INFECTION AND LOOSE COMPONENTS. TIBIA AND FEMUR WERE LOOSE. INFECTION REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7802556 ↗
• InjuryNov 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  CS POLY EXCHANGE POST A TKA.

  Patient problems: Injury

  MAUDE report 7029674 ↗
• InjuryJun 23, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  SALES REP REPORTED PATIENT WAS REVISED DUE TO PAINFUL KNEE, HOT BONE.

  Patient problems: Injury; Pain

  MAUDE report 6663529 ↗
• MalfunctionApr 25, 2017Fitting Problem; Connection Problem; Mechanics Altered; Positioning Problem; Fitting Problem; Positioning Problem

  POOR ENGAGEMENT OF THE PE ON THE TIBIAL BASE. USE OF OTHER IMPLANT OF THE SAME SIZE AND THICKNESS TO COMPLETE SURGERY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6518460 ↗
• InjuryJan 16, 2017Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS BEING REVISED FOR FLEXION INSTABILITY. FEMUR WAS REVISED AND REPLACED WITH TS FEMUR. POLY HAD SIGNIFICANT DAMAGE TO IT AT 9 MONTHS POST OP.

  Patient problems: Injury

  MAUDE report 6254527 ↗