Triathlon 5531-G-616Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327045987), received between Nov 16, 2020 and Feb 2, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  COMPONENTS REVISED DUE TO WEAR AND JOINT INSTABILITY. FRACTURE OF THE POSTEROLATERAL BEARING SURFACE WAS ALSO NOTED.

  Patient problems: Joint Laxity

  MAUDE report 16282696 ↗
• InjuryJan 4, 2022Degraded; Unstable; Degraded; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO MALPOSITION AND INSTABILITY. INTRA-OPERATIVELY THE FOLLOWING WAS NOTED: SLIGHT MALPOSITION OF FEMORAL COMPONENT, WORN INSERT WITH BROKEN LOCKING WIRE, AND BROKEN TIBIAL BASEPLATE. THE BASEPLATE WAS BROKEN MEDIALLY 1/3 OF THE WAY THROUGH THE ANTERIOR MEDIAL SPIKE. THE PATIENT WAS REVISED TO A TS KNEE WITH A UNIVERSAL BASEPLATE AND STEMS.

  Patient problems: Joint Laxity

  MAUDE report 13150844 ↗
• InjuryNov 16, 2020Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL AND UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY. *UPDATE ON 11-MARCH-2022 PER MEDICAL REVIEW: "[...] JUNE 28, 2017: THERE IS IN OPERATION REPORT FROM DR. THE PRE-AND POSTOP DIAGNOSIS WAS PAINFUL AND UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY. THE OPERATION PERFORMED WAS A REVISION LEFT TOTAL KNEE ARTHROPLASTY. THE IMPLANTS UTILIZED WERE A STRYKER TRIATHLON X3 19 MM POLYETHYLENE INSERT CS SIZE #6. OPERATIVE FINDINGS INCLUDED WELL FIXED IMPLANTS, NO PATELLA WEAR, MILD POSTERIOR MEDIAL TIBIAL INSERT WEAR, A FLEXION GAP THAT WAS EQUAL IN SIZE TO THE EXTENSION GAP, COMPETENT POSTERIOR CRUCIATE LIGAMENT, FEMORAL AXIAL ROTATION SLIGHTLY EXTERNAL TO THE TIBIA WITH THE TIBIAL ROTATION AT THE JUNCTION OF THE MEDIAL AND MIDDLE THIRD OF THE TIBIAL TUBERCLE. THERE WAS CLEAR YELLOW FLUID PRESENT BUT NO EVIDENCE OF INFECTION. A 19 MM CS INSERT PROVIDED SATISFACTORY STABILITY ACCORDING TO THE SURGEON. [...]"

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 10842680 ↗