Truliant 02-022-44-3517Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862305244), received between Mar 3, 2023 and Sep 25, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿(B)(4). (B)(4) RK REV 1. (B)(4) RK REV 3. (B)(4) LK REV IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 2 MONTHS AFTER A RIGHT 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: Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20305755 ↗
• InjurySep 25, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4). CASE-(B)(4) RK REV 1, CASE-(B)(4), RK REV 2, 2024-00014810 LK REV IS ASSOCIATED WITH THIS CASE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE. #N/A

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

  MAUDE report 20305738 ↗
• InjuryMar 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED BY LEGAL, APPROXIMATELY 8 MONTHS POST OP THE SECOND REVISION OF THE LEFT TKA, THIS MALE PATIENT UNDERWENT A THIRD REVISION AND THE OPTETRAK DEVICE WAS REMOVED. REASON FOR THE REVISION WAS NOT REPORTED. UPON INFORMATION AND BELIEF, PATIENT REQUIRED SEVERAL REVISION SURGERIES FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 16478790 ↗