Truliant 02-022-35-2511Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862304186), received between Aug 19, 2022 and May 13, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Naturally Worn

  AS REPORTED, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT SURGERY. APPROXIMATELY 11 MONTHS LATER, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR. BECAUSE THE PATIENT HAS FILED A SHORT FORM, IT APPEARS THAT THEY ARE ALLEGING PROSTHESIS WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Pain

  MAUDE report 25159617 ↗
• InjuryOct 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN IN RIGHT KNEE AFTER PRIMARY TOTAL KNEE ARTHROPLASTY AND OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 20397466 ↗
• InjuryAug 7, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 63 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, AND DISCOMFORT. 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; Pain

  MAUDE report 19930574 ↗
• InjuryJun 18, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN 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, SWELLING, INSTABILITY, AND DISCOMFORT WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF¿S MOBILITY AND 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: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19563975 ↗
• InjuryMay 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2022, 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: Discomfort; Failure of Implant; Insufficient Information; Pain

  MAUDE report 19352333 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT TKA, THE 55 Y/O FEMALE PATIENT'S ORIGINAL DOS POLY WAS REVISED FROM 2018 TO A 15MM PS INSERT. THE SURGEON DID A POLY SWAP INCREASED 4 MM OF THICKNESS FROM AN 11MM TO A 15MM. THE SURGEON STATED TIBIAL INSERT REMOVED AFTER 6 YEARS WAS FLAWLESS. THERE WAS NO WEAR OR IMPERFECTIONS VISIBLE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19000276 ↗
• InjuryFeb 1, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A PATIENT HAD AN INITIAL LEFT KNEE TOTAL ARTHROPLASTY ON (B)(6) 2019 AND THEN APPROXIMATELY 4 YEARS 7 MONTHS LATER EXPERIENCED A REVISION SURGICAL PROCEDURE ON 30 JAN 2024. THE PATIENT COMPLAINED OF PAIN. REVISION FOR LOOSE FEMUR AND RECALLED POLY. POLYETHYLENE WEAR. THE PATIENT REVISED TO EXACTECH DEVICES. REPORTED EVENT IS NOT RELATED TO BREAKAGE OF A DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED, THE HOSPITAL WILL NOT RELEASE IT. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18627219 ↗
• InjuryJun 15, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2019. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 3 YEARS 3 MONTHS AFTER THEIR PRIMARY PROCEDURE DUE TO INCREASING DEBILITATION AND PAIN. PREOPERATIVELY, ALL COMPONENTS APPEARED TO BE WELL FIXED AND IN GOOD POSITION ON X-RAY. HOWEVER, THE PATIENT HAD WHAT FELT TO BE COLLATERAL LIGAMENT LAXITY CAUSING INSTABILITY. SURGEON NOTED FINDING MODERATELY INFLAMED SYNOVIAL TISSUE. ALL COMPONENTS WERE WELL FIXED AND IN GOOD POSITION. THERE WAS MINIMAL WEAR OF THE POLYETHYLENE LINER. THERE WAS LIGAMENTOUS LAXITY WITH MEDIAL VARUS VALGUS STRESS, ESPECIALLY IN MID FLEXION. THE PATELLAR COMPONENT WAS WELL FIXED AND IN GOOD CONDITION. THERE WAS NO SIGNS OF OSTEOLYSIS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Joint Laxity; Joint effusion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17140104 ↗
• InjuryJun 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND THE APPROXIMATELY 11 MONTHS LATER, ON (B)(6) 2022, THEY EXPERIENCED A REVISION SURGERY FOR UNREPORTED REASONS. 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 17069785 ↗
• InjuryJun 2, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2021. THEY UNDERWENT LEFT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 1 YEAR 4 MONTHS AFTER THEIR INITIAL REPLACEMENT. THE REASON FOR REVISION HAS NOT BEEN PROVIDED. 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: Failure of Implant; Insufficient Information

  MAUDE report 17053226 ↗
• InjuryApr 14, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  LEGAL CASE PROSE (B)(6). RELATED CASE: (B)(4). PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 2 YEARS 4 MONTHS POST INITIAL SURGERY THE PATIENT HAD A RIGHT KNEE REVISION. 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. SERIAL #: (B)(4), CATEGORY #: 02-022-35-2511 - TRULIANT TIB IMP PS INSERT SZ 2.5 11MM, THE SERIAL NUMBER (B)(4), IS NOT AFFECTED BY THE RECALL. 510K: K152170. CONCOMITANTS: SERIAL #: (B)(4), CATEGORY #: 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT. SERIAL #: (B)(4), CATEGORY #: 02-012-60-1425 - LOGIC STEM EXT 14MM X 25MM. SERIAL #: (B)(4), CATEGORY #: 02-022-45-2525 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T. SERIAL #: (B)(4), CATEGORY #: 204-70-00 - TIBIAL STEM EXT. SCREW. SERIAL #: (B)(4), CATEGORY #: 02-020-11-0225 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5.

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

  MAUDE report 16742796 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 9 MONTHS POST THE INITIAL PROCEDURE DUE TO COMPLAINTS OF STIFFNESS IN THEIR LEFT KNEE. THE PATIENT PRESENTED WITH DECREASED FLEXION. UNDER ANESTHESIA, THE SURGEON ASSESSED THE ROM. A SYNOVECTOMY WAS PERFORMED AROUND ALL THE IMPLANTS. THE IMPLANT WAS REMOVED USING AN OSTEOTOME. THE ORIGINAL POLY SHOWED NO OBVIOUS ISSUES OR ABNORMALITIES. THE ORIGINAL POLY WAS TIGHT WITHIN THE KNEE JOINT AND TOOK MULTIPLE INSTRUMENTS TO REMOVE. THE SURGEON CONTINUED PERFORMING A SYNOVECTOMY AND USED A COBB TO PERFORM MINOR RELEASES WITHIN THE JOINT. THE SURGEON THEN USED A LOGIC STYLE SZ 2.5 - 9MM POLY TRAIL TO TRAIL THROUGH A ROM WITH A THINNER OPTION THAN WHAT WAS IN THERE, TO BEGIN WITH. THE SURGEON USED A MALLET ON THE POLY HANDLE TO HELP GET THE TRAIL INSERTED INTO THE TIBIA TRAY. ONCE THE TRAIL WAS INSERTED THE KNEE WAS TAKEN THROUGH A ROM. THE 9MM WAS DECIDED ON, AS IT HELPED INCREASE FLEXION AND STILL KEPT STABILITY. THE SURGEON REQUESTED FOR A NON-RECALLED SIZE 9MM FOR THE 2.5 FEMUR TO BE OPENED. THE KNEE JOINT AND SURROUNDING WOUND WAS

  Patient problems: Loss of Range of Motion

  MAUDE report 15629048 ↗
• InjuryAug 19, 2022Inadequacy of Device Shape and/or Size; Unstable; Inadequacy of Device Shape and/or Size; Unstable

  IT WAS REPORTED THAT A 69 YO FEMALE PATIENT, WHO WAS INITIALLY IMPLANTED ON THE RIGHT KNEE ON (B)(6) 2021, UNDERWENT A POLY SWAP REVISION SURGERY APPROXIMATELY 1 YEAR 1 MONTH POST THE INITIAL IMPLANT PROCEDURE DUE TO INSTABILITY. THEY INCREASED POLY THICKNESS FROM A 11MM PS INSERT TO A 15MM PSC INSERT AND WERE REVISED TO EXACTECH DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DUE TO HOSPITAL POLICIES, NO PRODUCTS ARE AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

  Patient problems: Joint Laxity

  MAUDE report 15257980 ↗