Truliant 02-022-51-2510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862312556), received between May 20, 2022 and Oct 25, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

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

• InjuryOct 25, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2021. THIS DEVICE HAS NOT BEEN EXPLANTED. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN AND DISCOMFORT, SWELLING, STICKING OF THE KNEE, IMPAIRED SLEEP, CLICKING, AND MOBILITY IMPAIRMENT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 18001653 ↗
• InjuryNov 18, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TWO YEAR POST INITIAL LEFT TKA, THE 57 Y/O FEMALE PATIENT'S POLY WAS SWAPPED TO A 13MM POLY. PATIENT'S REASON FOR REVISION WAS INSTABILITY. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15823269 ↗
• InjuryOct 19, 2022Naturally Worn; Naturally Worn

  AS REPORTED. APPROXIMATELY TWO YEARS POST INITIAL RIGHT SIDE TKA, FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A REVISION AND SYNOVITIS AND WEAR ON POLY WAS FOUND. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 15632979 ↗
• InjuryMay 20, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST TKA, PATIENT PRESENTED TO CLINIC WITH PAIN. A MAGNETIC RESONANCE IMAGING (MRI) SHOWED SYNOVITIS AND A REVISION WAS PERFORMED. SURGEONS COMMENTED THAT THE FEMUR AND TIBIA WERE BOTH WELL ALIGNED AND NOT MECHANICALLY LOOSE. THE PATELLA HAD SOME OSSIFICATIONS THAT THEY REMOVED. SURGEONS ALSO NOTED SYNOVITIS TISSUE AND REMOVED IT. THEY SAW SOME POSTERIOR WEAR ON THE INSERT WITH SOME DAMAGE TO THE POSTERIOR LEADING EDGE WITH SUSPECTED DAMAGE UPON ORIGINAL INSERTION. A NEW INSERT WAS PLACED OF SAME THICKNESS (10 CRC). PATIENT WAS LAST KNOW TO BE IN STABLE CONDITION. THE INSERT IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION AVAILABLE. X-RAYS AND PHOTOS RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 14459919 ↗

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-