Truliant 02-022-44-3513Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862305213), received between Aug 12, 2022 and Jun 14, 2024 — classified as 3 injuries.

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

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.

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.

• InjuryJun 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A TRULIANT DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 2 YEARS, 2 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: REVISION SURGERY, SYNOVITIS, BONE LOSS, LOSS OF MOBILITY, JOINT PAIN, AND SWELLING. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 19536649 ↗
• InjuryAug 23, 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 PSC TIBIAL INSERT 3.5X13MM. 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 17602606 ↗
• InjuryAug 12, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION. UNSTABLE KNEE AND POSTERIOR POLY WEAR WERE INDICATED. THE 13PSC WAS SWAPPED TO 17PSC. INITIAL IMPLANT DATE IS UNKNOWN. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED IMPLANTS ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL IS KEEPING THEM.

  Patient problems: Joint Laxity

  MAUDE report 15216238 ↗