Truliant 02-022-35-4511Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862304544), received between Jan 4, 2022 and Feb 20, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2021. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO PAIN AND RECALLED POLY. THERE WAS NO REPORTED BREAKAGE OF DEVICES 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity; Joint effusion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21426599 ↗
• InjuryAug 8, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, EFFUSION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Pain; Synovitis

  MAUDE report 19942501 ↗
• InjuryJun 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A TRULIANT DEVICE ON THE LEFT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN AND SUFFERING. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 19625945 ↗
• InjuryJul 17, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2022. APPROXIMATELY 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6)2023. THE PATIENT HAD AND WILL CONTINUE TO HAVE PAIN AND SUFFERING. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17332520 ↗
• InjuryJun 8, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT KNEE TOTAL ARTHROPLASTY ON (B)(6) 2021, AND THEN HAD A REVISION PROCEDURE ON (B)(6) 2023; APPROXIMATELY 1 YEAR, 9 MONTHS, AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023-POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE ARTHROPLASTY POLY DUE TO PREMATURE POLY WEAR AND POLY RECALL. CLINICAL HISTORY: PATIENT PRESENTED WITH CLINICAL PICTURE OF POLYETHYLENE WEAR WITH PAIN AND SWELLING OF RIGHT TOTAL KNEE. EVALUATION INCLUDED X-RAYS, WHICH SHOWED VISIBLE POLY WEAR. FINDINGS: THERE WAS A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS FOUND TO BE WELL-FIXED TIBIAL, FEMORAL, AND PATELLAR COMPONENTS WITH NO EVIDENCE OF SURROUNDING OSTEOLYSIS. THERE WAS FOUND TO BE A PALPABLE EVIDENCE OF POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE COMPONENT WITH EVIDENCE OF REACTIVE SYNOVIAL TISSUE SECONDARY TO POLYETHYLENE DEBRIS WITH ENCAPSULATED POLYETHYLENE. DRESSINGS WERE APPLIED WITH COMPRESSION WRAP. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION, THERE WERE NO COMPLICATIONS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THER

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 17087803 ↗
• InjuryMay 25, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  REVISION OP REPORT FINDINGS: ALL COMPONENTS WERE WELL FIXED. THE PATELLA WAS LEFT IN PLACE. THERE WAS A MILD TO MODERATE AMOUNT OF NORMAL-APPEARING JOINT FLUID. THERE WERE NO SIGNED OF INFECTION. THERE WAS SLIGHT HYPEREXTENSION ALONG WITH SUBTLE MID FLEXION INSTABILITY. THE PATIENT WAS THEN TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION THERE ARE NO COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Arthralgia; Failure of Implant; Joint Laxity; Pain

  MAUDE report 17007674 ↗
• InjuryMay 2, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 68 Y/O MALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. PATIENT WAS ORIGINALLY IMPLANTED WITH A 4.5 X 11MM PS INSERT. DURING REVISION, SURGEON UPSIZED POLY TO 15MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS ARE UNAVAILABLE. DEVICES ARE NOT RETUNING - HOSPITAL POLICY.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16852833 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY ONE-YEAR POST TKA, THE (B)(6), MALE PATIENT EXPERIENCED A GLOBAL LAXITY. PATIENT WAS SEEN IN CLINIC (B)(6) 2021 FOR COMPLAINTS OF KNEE LOCK, INCREASE IN PAIN, WEAKNESS, SWELLING AND GIVING WAY IN LEFT KNEE WITH HINGED KNEE CAGE BRACE PLACED FOR EXTRA SUPPORT. PATIENT WAS SEEN (B)(6) 2021 IN A TRUPULL BRACE WITH SOME IMPROVEMENT. PATIENT TO BE SCHEDULED FOR A POLYETHYLENE EXCHANGE FOR GLOBAL LAXITY. THE EVENT IS NOT RELATED TO THE DEVICE BUT DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 13159613 ↗