Truliant, Activit-E 02-024-51-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862601032), received between Aug 9, 2024 and Aug 9, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K223252); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2024, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT DEVELOPED SOFT TISSUE ADHESIONS. THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA WITH NO SUCCESS. THEY THEN UNDERTOOK A SURGICAL APPROACH TO FREE UP THE ADHESIONS AND PERFORMED A POLY EXCHANGE. LIKELY THEY WERE REMOVING THE POLY TO IMPROVE EXPOSURE AND AS IT¿S SINGLE USE HAD TO REPLACE WITH A NEW ONE. THERE DOESN¿T APPEAR TO BE ANY ALLEGED DEFECT WITH THE DEVICE. THERE WERE NO ISSUES WITH THE SURGERY. THE REP WILL TRY TO RETRIEVE THE DEVICE TO RETURN FOR ANALYSIS. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19954462 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223252. One submission often covers many models, so check the product and lot details in each record.

• Z-0586-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515,