Truliant 02-022-51-3517Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862307736), received between Mar 21, 2022 and Sep 30, 2024 — 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.

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.

• InjurySep 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 2 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Insufficient Information; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20333735 ↗
• InjuryAug 22, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 2 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, SWELLING, DISCOMFORT, INSTABILITY, AND LIMITED MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20032277 ↗
• InjuryAug 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REVISION SURGERY ON (B)(6) 2019. THE PATIENT HAS NOT YET UNDERGONE A SECOND REVISION SURGERY; HOWEVER, THEY HAVE REPORTED THE FOLLOWING INJURIES: PAIN, AND DIFFICULTY WALKING AND DIFFICULTY PERFORMING EVERYDAY ACTIVITIES. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. 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 MULTI-DISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTI-DISTRICT 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 MULTI-DISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A R

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 17649772 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE TRULIANT KNEE CLINICAL STUDY; APPROXIMATELY FOURTEEN DAYS POST INITIAL TKA, THIS (B)(6) FEMALE PATIENT CAME TO FOLLOW UP APPT WITH SWOLLEN KNEE. FLUID WAS DRAINED. PATIENT WAS THEN TRANSPORTED TO THE EMERGENCY DEPARTMENT FOR A SYNCOPAL EVENT. IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE WAS PERFORMED A DAY AFTER. CULTURES WERE TAKEN INTRA-OPERATIVELY SHOWN POSITIVE FOR INFECTION. PATIENT STARTED ON 6 WEEKS ANTIBIOTICS. PER CLINICAL STUDY THIS EVENT IS NOT RELATED TO THE DEVICE BUT RELATED TO THE PROCEDURE.

  Patient problems: Bacterial Infection

  MAUDE report 13839717 ↗