Triathlon 5532-G-413Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327050721), received between Nov 14, 2017 and Jul 1, 2025 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2025Mechanical Problem; Inadequacy of Device Shape and/or Size; Mechanical Problem; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ROM ISSUES (KNEE WAS TOO TIGHT). A 4X13 PS INSERT WAS REVISED TO A 4X11 PS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 22370307 ↗
• InjuryFeb 20, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. SURGEON NOTED THAT THE TIBIA WAS IN EXTERNAL ROTATION, BUT FELT IT WASN'T ENOUGH TO REVISE THE BASEPLATE. A 4X13 PS INSERT WAS REVISED TO A 4X19 PS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 18737371 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 YEAR FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "SORE AT NIGHT OR IF ON MY FEET ALL DAY. ALWAYS FEELS SOME PAIN AND IT POPS A LOT WHEN I MOVE IT."

  Patient problems: Pain

  MAUDE report 14191620 ↗
• InjuryApr 20, 2022Unstable; Unstable

  PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "ALWAYS PUTTING LIDOCAINE ON EVERY NIGHT TO GET TO SLEEP. NOT MUCH PAIN. HAVE FALLEN NUMEROUS TIMES. ALWAYS NERVOUS WALKING. KNEE STILL GIVES OUT, JUST FEELS TOO LOOSE."

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 14161029 ↗
• InjuryJun 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2020. AS REPORTED: "DOCTOR STATED 'DIAGNOSIS IS ARTHROFIBROSIS.' GOT LOST TO FOLLOWUP FOR 4 YEARS, AND DEVELOPED FLEXION CONTRACTURE. PATIENT WASHED OUT (B)(6) 2014, AND HAD POLY INSERT EXCHANGED. RIGHT SIDE. NOTHING WAS LOOSE OR BROKEN. GRAHM STAIN WAS NEGATIVE [FOR INFECTION]. THIS WILL BE ALL INFORMATION DUE TO HOSPITAL POLICIES." SPOKE TO REP. THE PATIENT'S PS KNEE CONSTRUCT WAS REVISED TO A TS KNEE ON (B)(6) 2020 DUE TO THE REPORTED FLEXION CONTRACTURE.

  Patient problems: Injury; Muscular Rigidity

  MAUDE report 10206160 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT PRIMARY LEFT TOTAL KNEE REPLACEMENT (B)(6) 2019. PATIENT HAD REVISION WITH POLY COMPONENT EXCHANGED FOR PERIPROSTHETIC JOINT INFECTION ON (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8821583 ↗
• InjuryJun 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SUSPECTED INFECTION (IT WAS NOT REPORTED TO THE REP IF THE INFECTION WAS CLINICALLY CONFIRMED OR THE INFECTING MICROORGANISM IDENTIFIED). SURGEON PERFORMED A WASHOUT WITH POLY SWAP. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8697199 ↗
• InjuryJan 3, 2019Unstable; Unstable

  THE DOCTOR REVISED A TIBIAL INSERT FROM A 4X13 TO A 4X16 DUE TO PAIN/INSTABILITY. NO ISSUES WERE OBSERVED WITH THE INSERT IMPLANT. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2016. UPDATE 06/DECEMBER/2018: REP PROVIDED A PRIMARY OPERATIVE REPORT WITH IMPLANT INFORMATION, X-RAYS, AND REVISION IMPLANT SHEET AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Pain

  MAUDE report 8213057 ↗
• InjuryNov 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. INTRA-OPERATIVELY, NOTHING WAS FOUND LOOSE. A 13MM PS INSERT WAS REVISED TO A 16MM PS INSERT.

  Patient problems: Injury

  MAUDE report 8080964 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED AFTER SURGEON REPORTED LIMB LENGTH DISCREPANCY. A SIZE 4 13MM PS INSERT WAS REVISED TO A SIZE 4 9MM PS INSERT.

  Patient problems: Injury

  MAUDE report 7615668 ↗
• MalfunctionFeb 22, 2018Detachment Of Device Component; Device Operates Differently Than Expected; Detachment Of Device Component; Device Operates Differently Than Expected

  AS REPORTED: "SURGEON, DURING BILATERAL TOTAL KNEES, TRIED TO LOCK THE INSERT IN TO THE TIBIAL TRAY OF THE RIGHT KNEE, WHEN IT DIDN¿T LOCK HE USED A OSTEOTOME TO WORK THE INSERT BACK OUT AND WHEN HE DID HE STATED THAT THE WIRE FELL OFF. THIS HAPPENED A SECOND TIME WITH ANOTHER INSERT IN THE SAME KNEE. WE DID NOT HAVE ANY OTHER INSERT AS WE HAD USED TWO. SURGEON DECIDED TO LEAVE AN INSERT TRIAL IN AND COME BACK ON FRIDAY(B)(6) 2018 TO PUT ANOTHER INSERT IN AT THAT TIME."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7290213 ↗
• MalfunctionFeb 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED: "SURGEON, DURING BILATERAL TOTAL KNEES, TRIED TO LOCK THE INSERT IN TO THE TIBIAL TRAY OF THE RIGHT KNEE, WHEN IT DIDN¿T LOCK HE USED A OSTEOTOME TO WORK THE INSERT BACK OUT AND WHEN HE DID HE STATED THAT THE WIRE FELL OFF. THIS HAPPENED A SECOND TIME WITH ANOTHER INSERT IN THE SAME KNEE. WE DID NOT HAVE ANY OTHER INSERT AS WE HAD USED TWO. SURGEON DECIDED TO LEAVE AN INSERT TRIAL IN AND COME BACK ON FRIDAY (B)(6) 2018 TO PUT ANOTHER INSERT IN AT THAT TIME."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7289664 ↗
• InjuryJan 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF TOTAL KNEE ARTHROPLASTY FOR INSTABILITY.

  Patient problems: Injury

  MAUDE report 7191425 ↗
• InjuryNov 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT COMPLAINED OF INSTABILITY IN HER LEFT TOTAL KNEE THAT WAS REPLACED IN 2016 WITH TRIATHLON PS COMPONENTS. REVISION PERFORMED AND A TS INSERT WAS UTILIZED TO CORRECT INSTABILITY.

  Patient problems: Injury

  MAUDE report 7028446 ↗