Truliant 02-022-47-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862306425), received between Sep 7, 2022 and Aug 9, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  LEGAL CASE-USA. LOR FORM RECEIVED IN COMPLAINT INBOX ON 06DEC2023. NO INFORMATION PROVIDED OTHER THAN PATIENT NAME. EBI DATA WAS IDENTIFIED BASED ON PATIENT'S NAME ONLY AND CASE UPDATED. NO INFORMATION ABOUT REVISION OR SURGERY OPS REPORTS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19949925 ↗
• InjuryMay 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2023, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Swelling/ Edema

  MAUDE report 19405987 ↗
• InjuryMay 13, 2024Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 67 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 3 YEARS 9 MONTHS POST OP. THE PATIENT HAD AN ORIGINAL EXACTECH TKA. THE PATIENT RETURNED TO SURGEONS OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2024. THE PATIENT UNDERWENT POLY TIBIAL INSERT SWAP AND PATELLA SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT

  Patient problems: Failure of Implant; Joint Laxity; Joint effusion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19306593 ↗
• InjuryFeb 6, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 61 Y/O FEMALE PATIENT HAD AN ORIGINAL BILATERAL TKA PROCEDURE WITH EXACTECH IMPLANTS. THE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF THEIR TKA'S AND KNOWN RECALLED POLYETHYLENE IMPLANTS. THE PATIENT ALREADY UNDERWENT A RIGHT TKA REVISION POLY SWAP AND IS NOW HAVING THE LEFT TKA POLY SWAP. THE PATIENT WAS SCHEDULED FOR A LEFT KNEE REVISION POSSIBLE POLY SWAP AND PATELLA RESURFACING. PATIENT WAS REVISED TO TRULAINT CRC TIABIAL INSERT SZ 3.5, MM AND OPTETRAK 3 PEG PATELLA CEMENTED MM 32. THE PATIENT LEFT THE OR STABLE. SALES REP WAS UNABLE TO OBTAIN X-RAYS OR PHOTOS.

  Patient problems: Discomfort; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 18651423 ↗
• InjuryDec 26, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 61 Y/O FEMALE PATIENT HAD AN ORIGINAL BILATERAL TKA PROCEDURE WITH EXACTECH IMPLANTS ON (B)(6) 2019. PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF THEIR TKA'S AND KNOWN RECALLED POLYETHYLENE IMPLANTS. THE PATIENT WAS SCHEDULED FOR A RIGHT KNEE REVISION POSSIBLE POLY SWAP AND PATELLA RESURFACING ON (B)(6) 2023. THE PATIENT UNDERWENT A TIBIAL POLYETHYLENE SWAP AND PATELLA RESURFACING. PATIENT WAS REVISED TO TRULIANT CRC TIBIAL INSERT SZ 3.5, 15MM AND OPTETRAK 3 PEG PATELLA CEMENTED 32MM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT LEFT THE OR STABLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND IMAGES RECEIVED, THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO IT WAS DISCARDED AT THE FACILITY.

  Patient problems: Discomfort; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 18395143 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH (B)(6) CLINICAL STUDY, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019. THE PATIENT PRESENTED ON (B)(6) 2023 WITH PAIN IN THE CAPSULE AREA OF BOTH KNEES. THIS CASE IS RELATED TO (B)(4) (LEFT SIDE). THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO DEVICE AND/OR TO PROCEDURE. OUTCOME IS CONTINUING WITH REFERRAL TO PAIN MANAGEMENT FOR NERVE OBLATIONS. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: Implant Pain; Pain

  MAUDE report 18280314 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. THE PATIENT PRESENTED ON (B)(6) 2023 WITH PAIN IN THE CAPSULE AREA OF BOTH KNEES. THIS CASE IS RELATED TO CASE- (B)(4) (RIGHT SIDE). THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO DEVICE AND/OR TO PROCEDURE. OUTCOME IS CONTINUING WITH REFERRAL TO PAIN MANAGEMENT FOR NERVE OBLATIONS. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: Implant Pain; Pain

  MAUDE report 18280303 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, THE 67 Y/O MALE PATIENT HAD A REVISION FOR AN UNKNOWN REASON. SURGEON PERFORMED A POLY SWAP. PATIENT WAS REVISED TO EXACTECH DEVICE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE SALES REP WAS UNABLE TO OBTAIN X-RAYS OR IMAGES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE HOSPITAL KEPT IMPLANTS.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17554719 ↗
• InjuryJun 5, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL TKA, THE 66 Y/O FEMALE HAD A REVISION OF THE POLY INSERT FOR AN UNKNOWN REASON. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Joint effusion; Osteolysis; Pain

  MAUDE report 17067089 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 69 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS 7 MONTHS POST THE INITIAL PROCEDURE TO SWAP THE RECALL IMPLANT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT RETURNING AS THE HOSPITAL REFUSED TO RETURN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15573386 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 3 MONTHS POST OP THE INITIAL TKA, THIS 53 Y/O FEMALE PATIENT WAS EXPERIENCING INCREASED PAIN AND STIFFNESS. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND UNLIKELY RELATED PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. ACTION TAKEN: MEDICATION. X-RAYS. FOLLOW UP IN FOUR MONTHS PER DOCTOR'S INSTRUCTIONS.

  Patient problems: Failure of Implant; Pain; Unspecified Musculoskeletal problem

  MAUDE report 15391196 ↗
• InjurySep 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. THE PATIENT HAD A POLY SWAP AND WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION OR MEDICAL HISTORY PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15370240 ↗