Triathlon 5532-G-613-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327338331), received between Dec 21, 2022 and Jul 31, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105487 ↗
• InjuryJun 19, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO COLLATERAL LIGAMENT INSTABILITY. A 6X13 PS INSERT WAS REVISED TO A 6X19 TS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 22293123 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL FROM SURGEON: BILATERAL TKR 2021 UNEXPECTED SWELLING : PATIENT HAS ASKED IF ANY LINER FAILURES WITH HIS BATCH OF IMPLANTS. THIS PI WAS OPENED TO CAPTURE THE RIGHT SIDE.

  Patient problems: Swelling/ Edema

  MAUDE report 20134146 ↗
• InjuryDec 21, 2022Unstable; Unstable

  AFTER REVISION SURGERY ON (B)(6) 2021, THE PATIENT CONTINUED TO EXPERIENCE PAIN AND ¿MID FLEXION INSTABILITY¿ AND WAS REVISED ON (B)(6) 2022 TO COMPETITOR PRODUCT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16022606 ↗

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-1265-2024 · 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-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1266-2024 · 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-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