Truliant 02-022-47-2509Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862306326), received between Oct 4, 2022 and Jul 12, 2023 — classified as 4 injuries.

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

2 FDA recall records name this device's identifier, 2 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. Nov 21, 2023Class IIOpen, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0585-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

2. 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.

• InjuryJul 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION 57 Y/O FEMALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 3 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON (B)(6) 2022 DIAGNOSIS: POLYETHYLENE FAILURE PRIOR TO SURGERY: PATIENT STARTED TO HAVE AN EFFUSION ASSOCIATED WITH POLYETHYLENE RECALL AND WORKUP OF THE EFFUSION WAS NEGATIVE FOR INFECTION WITH NEGATIVE ESR AND CRP, NEGATIVE FOR FRANK LOOSENING AND OSTEOLYSIS ON THE CT SCAN. SHE WAS AWOKEN AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS OCCURRED THROUGHOUT THE CASE.

  Patient problems: Failure of Implant; Joint effusion; Pain

  MAUDE report 17307044 ↗
• InjuryApr 6, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 3.3 YEARS POST INITIAL RIGHT TKA, THE 47 Y/O FEMALE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH RIGHT KNEE INSTABILITY AND CONFIRMED RECALLED POLYETHYLENE. THE PATIENT WAS SCHEDULED FOR A RIGHT TKA REVISION POLY SWAP AND PATELLA RESURFACING WITH AN IMPLANT. THE PATIENT HAD A REVISION RIGHT KNEE PROCEDURE WHERE THE ORIGINAL POLY IMPLANT WAS REMOVED, AND A NEW THICKER 13MM CRC ANTERIOR STABILIZE INSERT WAS CHOSEN AND IMPLANTED. THE PATELLA WAS ALSO RESURFACED WITH A ROUND 32MM PATELLA IMPLANT. THE PATIENT LEFT THE OR STABLE. THERE WAS NO BREAKAGE OF THE DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANT GOES TO THE LAB AND THEN LEGAL AND IS RETAINED BY THE HOSPITAL.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 16696763 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2020. THE PATIENT PRESENTED WITH LEFT KNEE STIFFNESS, DECREASED ROM, AND PAIN. ACTION TAKEN: MEDICATION. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Arthrofibrosis; Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 15569371 ↗
• InjuryOct 4, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S RIGHT KNEE COMPONENTS WERE REVISED DUE TO THE RECALL.

  Patient problems: Failure of Implant; Joint effusion; Pain

  MAUDE report 15536497 ↗