Triathlon 5531-G-710-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327392234), received between Nov 12, 2019 and Apr 14, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K173849); they may or may not involve this specific model.

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 16, 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.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: SURGEON PERFORMED A RIGHT TOTAL KNEE I&D WITH TIBIAL INSERT EXCHANGE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24870055 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT REVISED DUE TO POSSIBLE INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." LEFT KNEE. A 7X10 CS INSERT WAS EXCHANGED FOR A 7X9 CS INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 19838676 ↗
• InjuryJun 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO STIFFNESS IN THE JOINT. THE 10MM INSERT WAS REMOVED, SCAR TISSUE EXCISED AND POSTERIOR CAPSULE RELEASED. A NEW 10MM INSERT WAS THEN IMPLANTED. THE USE OF MAKO IN THE PRIMARY SURGERY WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS COMPLICATION. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 19525459 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO INFECTION. THE INSERT WAS REMOVED, JOINT WASHED OUT AND A NEW INSERT WAS PLACED. THERE WAS NO MENTION OF MAKO CONTRIBUTING TO THIS COMPLICATION. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 18299583 ↗
• InjuryNov 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO STIFFNESS. IT WAS DISCOVERED THAT THE LOCKING WIRE WAS DISENGAGED FROM THE BASEPLATE. SURGEON REPORTED HE SUSPECTS THE INSERT WAS NEVER LOCKED IN PROPERLY. A 7X10 CS INSERT WAS REVISED TO A 7X9 CS INSERT. REP REPORTED THAT HE CAN PROVIDE PICTURES AND POSSIBLY OBTAIN THE EXPLANTED INSERT FOR RETURN.

  Patient problems: Loss of Range of Motion

  MAUDE report 12813451 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DIAGNOSED WITH POST-TRAUMATIC TRICOMPARTMENTAL GONARTHROSIS, TOTAL PROSTHESIS IMPLANT SURGERY PERFORMED, USE OF CS POLYETHYLENE INSERT. DEVICE IMPLANTED ON (B)(6) 2021. APPEARANCE OF ACUTE PERIPROSTHETIC INFECTION OF THE KNEE DIAGNOSED CLINICALLY AND BY MICROBIOLOGICAL EXAMINATION OF JOINT FLUID. DEVICE REMOVED ON (B)(6) 2021. ACUTE PERIPROSTHETIC KNEE INFECTION. ON (B)(6) 2021 A SURGICAL DAIR (DEBRIDEMENT AND IMPLANT RETENTION) WAS PERFORMED WITH SOFT TISSUE DEBRIDEMENT, WASHING AND POLYETHYLENE REPLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 11668853 ↗
• InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON. UNKNOWN IF CLINICALLY CONFIRMED OR IF INFECTING MICROORGANISM IDENTIFIED). SURGEON PERFORMED A POLY SWAP OF A 7 X 10 CS INSERT FOR ANOTHER 7 X 10 CS INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9311422 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173849. One submission often covers many models, so check the product and lot details in each record.

• Z-1259-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 3 10 MM
• Z-1260-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 10 MM
• Z-1653-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E