Truliant 02-022-51-4015Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862307781), received between Aug 30, 2022 and Feb 26, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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

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.

• InjuryFeb 26, 2025Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE AND WAS REVISED TO SAME COMPANY DEVICES. IMPLANT AND EXPLANT DATES UNKNOWN. BAD POLY WAS INDICATED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN. THEY WENT TO PATHOLOGY. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21474639 ↗
• InjuryAug 14, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  LEGAL CASE - USA (B)(4). IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SUFFERED FROM PAIN, SWELLING, AND DECREASED RANGE OF MOTION. THE IMPLANTATION OF THE EXACTECH DEVICE AND SUBSEQUENT REVISIONS HAVE CAUSED PERSONAL INJURIES, SEVERE PAIN AND SUFFERING, MENTAL ANGUISH, EMOTIONAL DISTRESS, FEAR, LOSS OF ENJOYMENT OF LIFE, MEDICAL EXPENSES, AND FINANCIAL LOSSES, AND HE WILL SUSTAIN FUTURE DAMAGES INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE, REHABILITATION, MENTAL AND EMOTIONAL DISTRESS, AND PAIN AND SUFFERING. ACCORDINGLY, PLAINTIFF IS SEEKING COMPENSATORY AND SPECIAL DAMAGES, INCLUDING ATTORNEYS' FEES AND COSTS, AND ALL OTHER AVAILABLE REMEDIES UNDER THE LAW. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19987410 ↗
• InjuryJul 29, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 68 YO MALE PATIENT EXPERIENCED A PATELLA TENDON RUPTURE. AFTER REPORTING INCREASED PAIN IN CLINIC ON (B)(6) 2022, THE X-RAYS SHOWED THE PATELLA TO BE HIGH-RIDING. THE SURGEON DETERMINED THE PATELLA TENDON HAD RUPTURED, AND PATELLA-TENDON REPAIR SURGERY WAS SCHEDULED. THE PATIENT WAS REVISED ON (B)(6) 2022. THE OUTCOME WAS LAST KNOWN AS RESOLVED.

  Patient problems: Implant Pain; Muscle/Tendon Damage; Pain

  MAUDE report 17421510 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDIES, EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 63 YO MALE PATIENT, 102 KG, WHO WAS INITIALLY IMPLANTED ON (B)(6) 2022, FOR THE PRIMARY DIAGNOSIS OF OSTEOARTHRITIS, REPORTED INCREASED PAIN IN THE CLINIC ON (B)(6) 2022. XRAYS SHOWED THE PATELLA TO BE HIGH-RIDING. SURGEON DETERMINED THE PATELLA TENDON HAD RUPTURED, AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, 1 MONTH POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED WITH EXACTECH DEVICES. PATELLA TENDON REPAIRED. THE CASE REPORT INDICATES THE EVENT IS POSSIBLY RELATED TO THE PROCEDURE AND DEFINITELY NOT RELATED TO THE DEVICE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITIONS AND A RUPTURED PATELLA TENDON.

  Patient problems: Muscle/Tendon Damage; Pain

  MAUDE report 15324836 ↗