Triathlon 5531-G-213Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327045673), received between Oct 16, 2018 and Jan 8, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO FLEXION INSTABILITY. A 2X13 CS INSERT WAS REVISED TO A 2X19 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 21108358 ↗
• InjuryFeb 27, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. INTRA-OPERATIVELY, WEAR WAS NOTED ON THE POSTERIOR MEDIAL ASPECT OF THE INSERT. A 2X13 CS INSERT WAS REVISED TO A 2X19 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 16441558 ↗
• InjuryApr 13, 2021Degraded; Fracture; Degraded; Fracture

  THE CUSTOMER REPORTED THAT HE REVISED A TRIATHLON FOR INSTABILITY AND OPENED THE KNEE TO DISCOVER THAT THE POLY INSERT HAD BROKEN WHICH HAS CAUSED THE INSTABILITY. THE PATIENT HAD A FALL IN (B)(6) 2020. THE SURGEON ALSO REPORTED THAT THE PATELLA HAD A WEAR PATTERN WHICH THE SURGEON BELIEVES IS NOT RELATED TO THE IMPLANT BEING BROKEN. THE TKR WAS INITIALLY DONE ON (B)(6) 2010.

  Patient problems: Fall

  MAUDE report 11654687 ↗
• InjuryDec 22, 2020Unstable; Unstable

  PROCEDURE: THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY (B)(6) 2015. PATIENT HAD RIGHT KNEE PAIN AND INSTABILITY FOR MORE THAN TWO YEARS. THEN PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION ON (B)(6) 2020. ALL COMPONENTS EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11055290 ↗
• MalfunctionJun 12, 2019Material Integrity Problem; Material Integrity Problem

  OPENED INSERT TO THE FIELD AND SURGEON NOTICED SOME LINES ON THE TOP SIDE OF THE POLY. UPDATE MAY 31, 2019: AS PER SALES REP PHONE CALL, "THE MARKS LOOKED LIKE UNFINISHED MACHINING GOUGES NOT MATERIAL TRANSFER." UPDATE: "RIGHT SIDE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8691299 ↗
• InjuryMay 22, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE REPLACEMENT, TIBIAL LOOSENING AND INSTABILITY".

  Patient problems: Injury

  MAUDE report 8631554 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT (B)(6) 2018. THEN PATIENT HAD A LEFT REVISION KNEE ARTHROPLASTY, POLYETHYLENE LINER EXCHANGE AND IRRIGATION AND DEBRIDEMENT OF THE HEMATOMA (B)(6) 2018.

  Patient problems: Hematoma; Injury

  MAUDE report 7971080 ↗