Truliant 02-022-47-3009Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862306371), received between May 26, 2022 and Sep 10, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, EFFUSION, INSTABILITY, DIFFICULTY WALKING AND EMOTIONAL DISTRESS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Distress; Emotional Changes; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20183650 ↗
• InjuryAug 15, 2024Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SCARRING, BONE LOSS, SWELLING, EFFUSION, GAIT AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Joint Laxity; Joint effusion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection

  MAUDE report 19991802 ↗
• InjuryAug 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 72 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE RECALLED POLY. WHEN CONDUCTING SEARCH OF THE SERIAL, IT WAS DETERMINED THAT THE NUMBER IS NOT AFFECTED BY THE RECALL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DELAY OR PROLONGATION. NO X-RAYS OR PHOTOS PROVIDED. DEVICE IS NOT RETURNING - HOSPITAL KEPT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17479030 ↗
• InjuryJun 29, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2020. THEY HAD RIGHT KNEE REVISION SURGERY (B)(6) 2023, APPROXIMATELY 3 YEARS 3 MONTHS AFTER THEIR INITIAL PROCEDURE. PER (B)(6) 2023 OP REPORT: THE PATIENT HAD CHRONIC PAIN IN THE KNEE. BASED ON X-RAYS, IT WAS FELT THAT THE TIBIAL COMPONENT MIGHT BE OVERSIZED, BUT AT THE TIME OF SURGERY OF THE MEDIAL ASPECT OF THE TIBIAL TRAY WAS CLEARLY VISUALIZED AND THERE WAS NO OVERHANG. THE TIBIA APPEARED TO BE WELL-POSITIONED AND WELL SIZED. THE TIBIAL TRAY WAS CLOSELY INSPECTED AND FOUND TO BE STABLE WITHOUT ANY OVERHANG ON THE MEDIAL TIBIAL PLATEAU. POSTOPERATIVE DIAGNOSIS: SLING WEAR, RIGHT TOTAL KNEE. THE PATIENT WAS AWAKENED FROM ANESTHETIC AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. 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.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 17232473 ↗
• InjurySep 16, 2022Naturally Worn; Appropriate Device Problem Term/Code Not Available; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A 57 YO FEMALE PATIENT, WHO HAD THEIR RIGHT KNEE INITIALLY IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 2 YEARS 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR UNKNOWN REASONS TO EXCHANGE THE POLY INSERT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT ABLE TO BE RETURNED, AS THE HOSPITAL WOULD NOT RELEASE THE IMPLANT.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Joint effusion; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15438285 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY FIVE MONTHS POST INITIAL TKA, THE 73 Y/O FEMALE PATIENT COMPLAINTS OF STIFFNESS RIGHT KNEE AND PAIN, LIMITED RANG OF MOTION (ROM) AND MINIMAL DISCOMFORT. THE EVENT IS STILL ONGOING, PATIENT IS TAKING MEDICATION AND ORDERED PHYSICAL THERAPY (PT). PER CLINICAL STUDY CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Pain

  MAUDE report 14632740 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY FIVE MONTHS POST INITIAL TKA, THE 54 Y/O FEMALE PATIENT COMPLAINT OF STIFFNESS TO RIGHT KNEE. NO IMPROVEMENT WITH PHYSICAL THERAPY (PT). THE EVENT IS STILL ONGOING. PER CLINICAL STUDY CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Pain

  MAUDE report 14519259 ↗