Triathlon 5530-G-209Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327046410), received between Jan 24, 2017 and Apr 10, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2025Degraded; Fracture; Degraded; Fracture

  PATIENT HAD A FALL AND REQUIRED A REVISION KNEE REPLACEMENT DUE TO FRACTURE AND WEAR OF THE POLY. UPON INVESTIGATION INTRA-OP THIS SEEMED TRUE AS THE POSTERIOR CORNER OF THE POLY SNAPPED OFF. UPON CLOSE EXAMINATION IT APPEARED WE HAD REMOVED THE ENTIRE POLY. REPLACED POLY WITH A NEW IMPLANT.

  Patient problems: Fall

  MAUDE report 21813385 ↗
• InjuryFeb 15, 2024Degraded; Fracture; Material Fragmentation; Naturally Worn; Degraded; Fracture; Material Fragmentation; Naturally Worn

  PATIENT HAD RECEIVED A PRIMARY TKA IN 2012 THOUGH UNDERWENT REVISION SURGERY DUE TO ONGOING INSTABILITY ISSUES. INITIAL EXAMINATION DURING SURGERY ((B)(6 2024) DEMONSTRATED INCREASED MEDIAL/LATERAL LAXITY. SURGEON DISCOVERED FRAGMENTS OF INITIAL CR SIZE #2 9MM POLY AROUND THE KNEE JOINT WITH SIGNIFICANT WEAR ON THE POSTEROMEDIAL AND POSTEROLATERAL SURFACES. SURGEON REMOVED FRAGMENTS OF INSERT AND REPLACED WITH A CS SIZE #2 13MM POLY.

  Patient problems: Joint Laxity

  MAUDE report 18710375 ↗
• InjuryJun 28, 2022Degraded; Fracture; Unstable; Degraded; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PAIN AND DEFORMITY. " A BASEPLATE, INSERT, AND PATELLAR COMPONENT WERE REVISED.

  Patient problems: Deformity/ Disfigurement; Joint Laxity; Pain

  MAUDE report 14846450 ↗
• InjuryOct 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND STIFFNESS. INTRA-OPERATIVELY, A PIECE WAS FOUND CHIPPED OFF OF THE LINER POSTERIORLY. SURGEON PERFORMED AN I&D AND WASHOUT WITH LINER EXCHANGE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 12712293 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PR WAS RAISED FROM A MEDICAL REVIEW. THE PATIENT HAD LEFT KNEE ARTHROPLASTY ON (B)(6) 2011. A QUAD REPAIR WAS CARRIED OUT SIX MONTHS POST IMPLANTATION. REVISION SURGERY TOOK PLACE ON (B)(6) 2012 DUE TO INSTABILITY WHEREBY THE INSERT WAS REVISED. REVISION SURGERY TOOK PLACE ON (B)(6) 2016 DUE TO SUBSIDENCE AND INSTABILITY WHEREBY ALL COMPONENTS WERE REVISED. THIS PR IS FOR THE REVISION FOR QUAD REPAIR IN OR AROUND (B)(6) 2011.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 12497317 ↗
• InjuryNov 12, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A POSTERIOR FRACTURE OF THE POLY INSERT. A 2 X 9 CR INSERT WAS REVISED TO A 2 X 13 CS INSERT. THE DEVICE IS ALLEGEDLY AVAILABLE FOR RETURN, AND THE REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9311420 ↗
• InjuryApr 4, 2019Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LEFT TOTAL KNEE ARTHROPLASTY INSTABILITY PLUS LOOSE."

  Patient problems: Inadequate Osseointegration; Injury; Joint Laxity

  MAUDE report 8482413 ↗
• MalfunctionJan 24, 2017Mechanical Problem; Positioning Problem; Positioning Problem

  REP REPORTED THE SPRING MECHANISM FAILED DURING A PRIMARY RIGHT KNEE SURGERY. A REPLACMENT DEVICE WAS AVAILABLE, NO DELAY OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6272895 ↗