Triathlon 5531-G-413-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327337396), received between Sep 9, 2022 and Aug 14, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Unstable” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K172634); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INDEX TKA. PATIENT PRESENTED WITH PJI ON THE RIGHT KNEE, UNDERWENT REVISION. ONLY THE POLY WAS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 22806014 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT. REPORTED THEY CONTINUED EXPERIENCING PAIN, AND SWELLING. ON ANTI INFLAMMATORY MEDICATION FOR PAIN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 20521558 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED PAIN AND WOULD LIKE TO KNOW MATERIAL COMPOSITION AND IF PARTS SUBJECT TO A RECALL.

  Patient problems: Pain

  MAUDE report 18657404 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY STRYKER SALES REP - REVISION COMPLETED ON (B)(6) 2022- CHANGE OF INSERT, PATIENT HAD A FALL AND TORN LIGAMENT.

  Patient problems: Damage to Ligament(s); Fall

  MAUDE report 15885787 ↗
• InjurySep 9, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THE INSERT AND FEMORAL COMPONENT WERE REVISED. REP SPECIFICALLY CONFIRMED WITH THE SURGEON THAT NO IMPLANTS WERE ALLEGED TO BE LOOSE OR BROKEN. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 15392897 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1654-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E