Triathlon 5532-G-410-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327390445), received between Feb 16, 2022 and Jun 13, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• InjuryJun 13, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT HAD A LEFT KNEE POLY EXCHANGE DUE TO INFECTION. SURGEON SWITCHED TO 9MM POLY FOR SLIGHT STIFFNESS. NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Loss of Range of Motion; Unspecified Infection

  MAUDE report 19526461 ↗
• InjuryApr 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: PRIMARY RIGHT TKA SURGERY WAS PERFORMED ON (B)(6) 2024. REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION ON (B)(6) 2024.

  Patient problems: Arthritis; Joint Dislocation; Pain

  MAUDE report 19056231 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY STRYKER SALES REP THAT PATIENT COMPLAINED CONSISTENT PAIN AND EFFUSION IN BOTH KNEES AFTER BILATERAL MAKO TKR SURGERY. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14070974 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSTOPERATIVE SERRATIA INFECTION WAS CONFIRMED. SINCE SERRATIA IS RARE, HE IS SUSPICIOUS OF THE STERILIZATION AND STORAGE CONDITIONS OF THE IMPLANTS. HE REQUEST AN IMMEDIATE INVESTIGATION AND REPORT ON THE STERILIZATION, STORAGE, AND WHETHER OR NOT THE SIMILAR EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 13545210 ↗

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