Truliant 02-022-51-3009Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862307637), received between Aug 4, 2022 and Jun 28, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023 AND PER THE INFORMATION PROVIDED, THE DEVICES REMAIN IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19631716 ↗
• InjuryJun 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A TRULIANT DEVICE ON THE RIGHT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S QUALITY OF LIFE. 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; Discomfort; Pain

  MAUDE report 19625514 ↗
• InjuryApr 26, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND THEN WAS REVISED ON (B)(6) 2023. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, SCARRING, NUMBNESS, INFLAMMATION, KNEE POPPING AND CLICKING, INSTABILITY, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Inflammation; Joint Laxity; Numbness; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19197057 ↗
• InjuryMay 11, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, ON (B)(6) 2021, THIS PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN EXACTECH KNEE SYSTEM. IN THE ENSUING TIME, THE PATIENT BEGAN TO SUFFER FROM SYMPTOMS INCLUDING BUT NOT LIMITED TO COMPONENT LOOSENING AND PAIN AND LACK OF MOBILITY. AS A RESULT OF THESE SYMPTOMS, THE PATIENT UNDERWENT A RIGHT KNEE REVISION SURGERY ON (B)(6) 2021, APPROXIMATELY 3 MONTHS AFTER THEIR INITIAL PROCEDURE. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Emotional Changes; Failure of Implant; Pain

  MAUDE report 16912783 ↗
• InjuryOct 20, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 1 YEAR 9 MONTHS POST THE INITIAL PROCEDURE DUE TO PAIN. THE SURGEON PERFORMED RELEASES AND WENT UP TO AN 11MM INSERT WITH GOOD ROM AND STABILITY. HE NOTED MILD SYNOVITIS AND POLY WEAR. THE DAMAGE OF THE INSERT WAS FROM USING OSTEOTOME TO REMOVE IT. PATIENT LEFT IN STABLE CONDITION. THE DEVICE IS NOT RETURNING AS IT IS STANDARD PROCEDURE TO NOT RELEASE EXPLANTS WITHOUT PATIENT CONSENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint effusion; Pain; Synovitis

  MAUDE report 15642702 ↗
• InjuryOct 14, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2021. THE PATIENT PRESENTED WITH PAIN AND SYNOVITIS AND WAS REVISED ON (B)(6) 2022. THE INSERT WAS EXCHANGED FOR A NEW INSERT OF THE SAME SIZE AND THE PATELLA WAS RESURFACED. ORIGINALLY THE PATELLA WAS NOT RESURFACED. THE INSERT HAD MINIMAL WEAR. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Pain; Synovitis

  MAUDE report 15612127 ↗
• InjuryAug 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THIS 70 YEAR OLD, FEMALE PATIENT HAD AN INITIAL RIGHT SIDE TKA ON (B)(6) 2021. THE PATIENT WAS REVISED ON (B)(6) 2022. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15165557 ↗