Truliant 02-022-51-3515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862307729), received between Mar 1, 2023 and Jul 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2023 AND THE POLY WAS SWAPPED TO A TRULIANT CRC TIBIAL INSERT SZ 3.5X15MM. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17368299 ↗
• InjuryMar 1, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, WHO WAS REVISED ON (B)(6) 2020, UNDERWENT A SECOND REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 2 YEARS 10 MONTHS POST THE FIRST REVISION PROCEDURE. THE PLAINTIFF CONTINUED TO EXPERIENCE PAIN IN HIS LEFT KNEE AND PROCEEDED WITH A RE-REVISION SURGERY TO REMOVE THE IMPLANT. THE POLYETHYLENE LINER PREMATURELY DEGRADED, AND THE PLAINTIFF ENDURED REVISION SURGERIES AND OTHER COMPLICATIONS DUE TO SEVERE PAIN, SWELLING, AND INSTABILITY IN THE KNEE AND LEG. THESE INJURIES WERE CAUSED BY ACCELERATED AND PREVENTABLE WEAR OF THE POLYETHYLENE INSERT. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE NATURE OF THE DEFENDANTS¿ OPTETRAK DEVICES, THE PLAINTIFF SUFFERED AND WILL CONTINUE TO SUFFER SERIOUS PERSONAL INJURIES, INCLUDING PAIN, IMPAIRED MOBILITY, REHABILITATION, MEDICAL CARE, LOSS OF ENJOYMENT OF LIFE, AND OTHER MEDICAL AND NONMEDICAL SEQUELAE. AS A DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICES AS DESCRIBED HEREIN, THE PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO,

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Osteolysis; Pain

  MAUDE report 16464901 ↗