Truliant 02-022-47-2009Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862306272), received between Dec 29, 2022 and Dec 11, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 10 MONTHS POST THE PREVIOUS REVISION SURGERY, THE PATIENT HAD KNEE PAIN AND THE SURGEON DECIDED TO REVISE AGAIN BECAUSE THE FEMORAL AND TIBIAL COMPONENTS HAD BEEN FOUND TO BE LOOSE. THE PATIENT EXPERIENCED IMPLANT PAIN AND OSTEOLYSIS. METALLOSIS WAS FOUND AND ALL PROLIFERATIVE TISSUE REMOVED, THEN ALL COMPONENTS WERE REPLACED TO COMPETITOR DEVICES. 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 FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Metal Related Pathology; Osteolysis

  MAUDE report 20902550 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA (MDL NO. (B)(4) (NGG) (MMH). RELATED CASE: (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 18 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, EXPERIENCE PAIN, SENSITIVITY, DISCOMFORT, SWELLING AND/OR OTHER INJURIES AND COMPLICATIONS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 20037741 ↗
• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 63 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, WEAKNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Pain

  MAUDE report 19315315 ↗
• InjuryMar 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 11 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18950058 ↗
• InjuryAug 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP INITIAL LEFT TKA, THIS 70 Y/O FEMALE PATIENT WAS REVISED. SURGEON PERFORMED A POLY SWAP OF THE RECALLED POLY. REASON FOR THE REVISION WAS NOT REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE NOT RETURNING -HOSPITAL KEPT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17478799 ↗
• InjuryApr 20, 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 VIA LEGAL DOCUMENTATION, THIS PATIENT IS VERIFIED RIGHT KNEE ON (B)(6) 2016, WHICH WAS REVISED ON (B)(6) 2022. SHE WAS ADMITTED BACK IN THE HOSPITAL (B)(6) 2023 (APPROXIMATELY 5 MONTHS AFTER REVISION SURGERY) AND CT RLE WITH/WITHOUT CONTRAST SHOWED SMALL SUPRAPATELLAR JOINT EFFUSION, THICK WALLED POPLITEAL FLUID COLLECTION. MRI R KNEE WITH/WITHOUT CONTRAST SHOWED SMALL R EFFUSION WITH SYNOVITIS, COMPLEX BAKER'S CYST. SHE UNDERWENT CT GUIDED DRAINAGE PER IR WITH CULTURES NEGATIVE. FINDINGS: THERE IS SUBSTANTIAL ACTIVITY SURROUNDING THE PROSTHETIC COMPONENTS OF THE RIGHT KNEE, PARTICULARLY THE FEMORAL AND PATELLAR PROSTHETIC COMPONENTS. IMPRESSION: SUBSTANTIAL RIGHT KNEE PERIPROSTHETIC ACTIVITY POTENTIALLY RELATED TO PROSTHESIS LOOSENING OR RECENT INSTALLATION/REVISION. INFECTED PROSTHESIS IS ALSO CONSIDERED. PATIENT WAS DISCHARGED HOME ON (B)(6) 2023. SHE CONTINUED TO HAVE INCREASED PAIN AND SWELLING THEREFORE SHE WAS REFERRED TO ANOTHER DOCTOR FOR FURTHER MANAGEMENT. SHE UNDERWENT ASPIRATION OF R KNEE AS AN INTERVENTION. ON ADMIT SHE WAS AFEBRILE. SHE WAS NOTED TO HAVE LEUKOCYTOSIS, WBC 18.7. SHE UNDERWENT RIGHT KNEE REVISION (B)(6) 2023 , APPROXIMATELY 6 MONTHS AFTER T

  Patient problems: Bacterial Infection; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 16778059 ↗
• InjuryApr 19, 2023Naturally Worn; Naturally Worn

  LEGAL CASE (B)(6). PER A REPORT FROM THE LEGAL DEPARTMENT, A 52 Y/O MALE PATIENT HAD AN INITIAL LEFT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 3 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2022. OP REPORT PRE & POST OPERATIVE DIAGNOSIS: LEFT TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE FAILURE ASSOCIATED WITH RECALL. PROCEDURE: LEFT TOTAL KNEE REVISION WITH POLYETHYLENE EXCHANGE AND RETAINED METALLIC IMPLANTS WITH ASSOCIATED SYNOVECTOMY. PATIENT WAS AWOKEN AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. 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; Discomfort; Emotional Changes; Joint effusion; Pain; Synovitis

  MAUDE report 16767925 ↗
• InjuryFeb 7, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF INDICATES THAT ON (B)(6) 2019 PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING AN INSERT MADE OF POLYETHYLENE. PATIENT UNDERWENT REVISION SURGERY OF HER LEFT KNEE ON (B)(6) 2022. AS A DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE, PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH REQUIRE ONGOING MEDICAL CARE.

  Patient problems: Failure of Implant; Joint effusion; Pain

  MAUDE report 16311479 ↗
• InjuryDec 29, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL TKA, THE 67 Y/O FEMALE PATIENT HAD A REVISION DUE TO THE DEVICE POLY RECALL; NO OTHER REASON REPORTED. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF A DEVICE OR A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS AND X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WOULD NOT ALLOW. NO ADDITIONAL INFORMATION.

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

  MAUDE report 16074871 ↗