Truliant, Activit-E 02-024-51-1513Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862600714), received between Sep 17, 2024 and Sep 17, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 16, 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.

• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 2 MONTHS POST OP. THE PATIENT WAS BROUGHT BACK FOR A RIGHT KNEE IRRIGATION AND DEBRIDEMENT AND POLY SWAP. THE POLY LINER WAS REMOVED WITH THE HELP OF AN OSTEOTOME. AFTER IRRIGATION AND DEBRIDEMENT WAS FINISHED A NEW 1.5 13MM CRC WAS IMPLANTED WITH 20CC INTERSEP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: ITEM WAS DISCARDED.

  Patient problems: Insufficient Information

  MAUDE report 20241190 ↗

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,