Truliant 02-022-47-4009Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862306470), received between Sep 13, 2022 and Nov 4, 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.

• InjuryNov 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED APPROXIMATELY 3 YEARS 8 MONTHS POST OP. PATIENT HAS HAD CONSISTENT PAIN AND EXPERIENCED KNEE BUCKLING. FOLLOWING THE SURGERY, SHE HAD TO COMPLETED PHYSICAL THERAPY, WATER THERAPY, AND MUSCLE STIM THERAPY BEFORE GETTING THE IMPLANTS REMOVED. SURGEON MENTIONED BONE LOSS AND OVERLAPPING DEVICE TO BONE. PATIENT WAS REVISED TO COMPETITORS DEVICE.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 20605835 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2019. THE PATIENT PRESENTED ON (B)(6) 2019 AND PRESENTED TO THE ER WITH SEVERE INFECTION, THE LEG WITH THE HARDWARE WAS THEN AMPUTATED. OUTCOME: RESOLVED ON (B)(6) 2019.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 17800454 ↗
• InjuryApr 13, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  REVISION OPERATIVE REPORT OF (B)(6) 2022. INDICATION FOR SURGERY, THIS 61 YO FEMALE HAS A RECALLED POLYETHYLENE LINER. THE PATIENT WAS HAVING POSTOPERATIVE PAIN AND HAD A NEGATIVE INFECTION WORK-UP. POLY EXCHANGE WAS DONE REPLACING THE 9MM TO A 10MM POLY. AT THE TIME OF SURGERY THERE WAS NOTED TO BE SOME OVERGROWTH OF BONE ALONG THE MEDIAL TIBIAL TRAY AS WELL AS AN OSSIFIED FRAGMENT IN THE POSTERIOR MEDIAL JOINT LINE THAT WAS REMOVED. THERE IS SOME MILD WEAR ON THE POSTERIOR MEDIAL CORNER OF THE POLYETHYLENE AND SOME MILD WEAR ALONG THE SURFACE OF THE POLYS THERE WAS NO SIGNIFICANT OSTEOLYSIS SEEN AND MINIMAL SYNOVITIS. STERILE DRESSINGS WERE APPLIED, AND THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION, THERE WERE NO SURGICAL COMPLICATION. 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; Pain; Synovitis

  MAUDE report 16731135 ↗
• InjurySep 13, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD INITIAL RIGHT KNEE IMPLANTED WITH RECALLED POLY ON (B)(6) 2019, WAS REVISED TO A LOGIC CC SYSTEM ON (B)(6) 2022, APPROXIMATELY 3 YEARS 2 MONTHS POST THE INITIAL IMPLANT PROCEDURE DUE TO WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15413610 ↗