Triathlon 5532-G-811Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327046359), received between Sep 28, 2018 and Nov 8, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY AND A CYST FORMING UNDER THE PATELLAR COMPONENT. THE PATIENT WAS REVISED FROM AN 8X11 PS INSERT TO AN 8X11 TS INSERT AND THE 39MM SYMMETRIC PATELLA WAS SWAPPED FOR ANOTHER OF THE SAME SIZE. ASIDE FROM THE PROVIDED PRIMARY USAGE SHEET, REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Cyst(s); Joint Laxity

  MAUDE report 12775128 ↗
• InjuryOct 2, 2019Break; Break

  SURGEON SCHEDULED REVISION KNEE SURGERY FOR PATIENT AFTER HE EXAMINED PATIENT AT OFFICE. PATIENT HAD INITIAL SURGERY ON (B)(6) 2012. IDENTIFIED AT REVISION SURGERY. SURGEON SUSPECTED POSSIBLE POST BREAKAGE PRIOR TO SURGERY. SURGEON PERFORMED REVISION SURGERY TO REPLACE PS INSERT IN WHICH THE POST SHEARED OFF OF TIBIAL INSERT.

  Patient problems: Injury

  MAUDE report 9145940 ↗
• InjuryOct 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION (CAUSES OR CONTRIBUTORS TO INFECTION NOT REPORTED. UNKNOWN IF CLINICALLY CONFIRMED. INFECTING MICROORGANISM NOT IDENTIFIED TO REP). AN I&D WAS PERFORMED WITH A POLY SWAP. AN 8X11 PS INSERT WAS REVISED TO ANOTHER 8X11 PS INSERT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7991763 ↗
• InjuryOct 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT KNEE WAS REVISED. AN 8X11 PS INSERT WAS SWAPPED FOR ONE OF A DIFFERENT LOT NUMBER.

  Patient problems: Injury

  MAUDE report 7981017 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION (SURGEON IDENTIFIED INFECTION AS E. COLI. UNKNOWN IF INFECTION WAS CLINICALLY CONFIRMED). AN I&D WITH A POLY EXCHANGE FOR THE SAME CATALOG # WAS PERFORMED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7918548 ↗