Truliant 02-022-35-4515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862304582), received between Feb 24, 2023 and Mar 6, 2025 — classified as 2 injuries.

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K171045); 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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0023-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 74 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2017, WAS REVISED IN (B)(6) 2025, APPROXIMATELY 7 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN, THEY HAD A RECALLED PATELLA AND INSERT. THEY WERE REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY IMAGES WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. CHAIN OF COMMAND, DUE TO THE RECALL THE HOSPITAL WILL NOT RELEASE THEM. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 21537842 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2017, PATIENT WAS IMPLANTED WITH THE DEVICE WHICH FAILED PREMATURELY, CAUSING PAIN AND DIFFICULTY WALKING, AMONG OTHER INJURIES AND AILMENTS. RECENTLY, PATIENT BEGAN EXPERIENCING PAIN, INSTABILITY, SWELLING, AND DIFFICULTY WALKING, AMONG OTHER INJURIES AND AILMENTS. AFTER (B)(6) 2022, PATIENT RECEIVED A RECALL LETTER REGARDING HIS EXACTECH DEVICE, AND HIS PHYSICIAN CONFIRMED THAT HE WAS IMPLANTED WITH A NOW-RECALLED DEVICE. PATIENT¿S PHYSICIAN DISCUSSED WITH PATIENT HIS CONCERNS REGARDING HIS RECALLED EXACTECH POLYETHYLENE INSERT AS WELL AS THE PAIN AND DISCOMFORT PATENT WAS RECENTLY EXPERIENCING. ON OR ABOUT (B)(6) 2022, PATIENT VISITED HOSPITAL AT WHICH TIME HE HAD FLUID DRAWN FROM HIS PAINFULLY SWOLLEN LEFT KNEE, RECEIVED A CORTISOL SHOT, AND WAS INFORMED THAT HE WOULD NEED TO UNDERGO A REVISION SURGERY. PATIENT IS CURRENTLY WAITING TO BE SCHEDULED FOR REVISION SURGERY WHICH IS LIKELY TO OCCUR IN THE COMING MONTHS.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16440774 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171045. One submission often covers many models, so check the product and lot details in each record.

• Z-0585-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-