Truliant 02-022-35-4509Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10885862304520), received between Jan 2, 2020 and Jul 17, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Naturally Worn” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K171045); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT TOTAL KNEE REPLACEMENT. THEY UNDERWENT RIGHT KNEE REVISION SURGERY, APPROXIMATELY 1 YEAR POST PRIMARY PROCEDURE. REVISION OP REPORT NOTED THE SYNOVIAL TISSUE LOOKED HEALTHY, AND THERE WERE NO SIGNS OF MUCUS OR PURULENCE OR SIGNIFICANT SYNOVITIS; HOWEVER, THERE WAS SIGNIFICANT SCAR TISSUE OF THE SYNOVIAL TISSUE. THE PATELLAR BUTTON WAS WELL-FIXED IN A GOOD POSITION. THERE WERE NO DAMAGE OR SIGNS OF DELAMINATION ON GROSS INSPECTION OF THE TIBIAL INSERT. THE COMPONENTS WERE WELL FIXED AND IN APPROPRIATE ALIGNMENT. THE SURGEON NOTED THAT THE PATIENT'S BONE QUALITY WAS QUITE POOR. THERE WERE NO INTRAOPERATIVE FRACTURES. 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: Arthrofibrosis; Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 25857360 ↗
• InjuryApr 29, 2026Naturally Worn

  REPORT #3 OF 3 FOR THIS EVENT. IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, A FEW WEEKS LATER, THE PATIENT EXPERIENCED PAIN. ONE (1) YEAR, FIVE (5) MONTHS LATER, THE PATIENT REPORTS PAIN AND DISSATISFACTION WITH IMPLANT FUNCTION. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE DUE TO LOOSE TIBIA. IT WAS NOTED THE TIBIA WAS LOOSE WITH ONLY FIBROUS INGROWTH AND THE FEMUR HAD MINIMAL BONE INGROWTH. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAS SUFFERED SEVERE PAIN AND LOSS OF MOBILITY DUE TO PROSTHESIS WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE. 510K; K171045 CONCOMITANT PRODUCTS: - TRULIANT PS POR FEM PS POR RIGHT SZ 4.5(CAT#02-020-12-0345/SERIAL# 5758187) - TRULIANT TIB IMP PS INSERT SZ 4.5 9MM(CAT#02-022-35-4509/SERIAL# 5316760) - ADVANCED PATELLA 32MM 3 PEG IMPLANT(CAT#200-07-32/SERIAL# 6857967)

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Pain

  MAUDE report 25027585 ↗
• InjuryMar 6, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 34 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FEMORAL LOOSENING, PAIN AND RECURRENT EFFUSIONS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING OF THE IMPLANT. INTRAOPERATIVELY THE SURGEON OBSERVED SOME SCAR TISSUE AROUND THE PATELLA BUTTON, BUT WAS WELL FIXED AND IN GOOD CONDITION, AND THE SURGEON ELECTED TO RETAIN IT. THE SURGEON OBSERVED, ON INSPECTION, SOME PITTING OF POLYETHYLENE INSERT. IT WAS NOTED THE FEMORAL COMPONENT WAS EASILY DIS-IMPACTED AND CAME OFF CLEANLY FROM THE CEMENT MANTLE CONSISTENT WITH LOOSENING. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint Laxity; Joint effusion; Pain; Scar Tissue

  MAUDE report 21539034 ↗
• InjuryOct 22, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS AND INSTABILITY. 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: Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 20509758 ↗
• InjurySep 30, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LATERAL JOINT PAIN, SYNOVITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0023-2022.

  Patient problems: Pain; Synovitis

  MAUDE report 20339390 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 20268738 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 79 Y/O MALE PATIENT'S RIGHT KNEE WAS REVISED. SURGEON CHANGED OUT AN EXACTECH TRULIANT P.S. INSERT DUE TO INFECTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: FACILITY KEPT PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 20239653 ↗
• InjuryAug 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 29 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, BONE LOSS, EFFUSION. ANTALGIC GAIT, INSTABILITY AND EMOTIONAL DISTRESS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Emotional Changes; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20085483 ↗
• InjuryAug 26, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4) IT WAS REPORTED THAT APPROXIMATELY 16 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20071572 ↗
• InjuryAug 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 13 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20022576 ↗
• InjuryJul 2, 2024Naturally Worn; Naturally Worn

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

  Patient problems: Insufficient Information

  MAUDE report 19657497 ↗
• InjuryApr 9, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020, WITH NO REVISION SURGERY REPORTED. THERE IS NO DEVICE INFORMATION PROVIDED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19068984 ↗
• InjuryNov 22, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2020. APPROXIMATELY 2 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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. REVISION OP REPORT ON 27 MAR 2023. DIAGNOSIS: FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO EARLY POLYETHYLENE WEAR. "HE HAD SYNOVITIS WITH EVIDENCE OF POLYETHYLENE DEBRIS IN THE GUTTERS. I DEBRIDED SOME OF THE SYNOVIAL TISSUE AND SENT THIS FOR CULTURE. I CLEARED OFF THE SCAR TISSUE FROM AROUND THE PATELLAR BUTTON. I THEREFORE DECIDED TO EXCHANGE IT. I USED A THIN SAW BLADE TO REMOVE THE PATELLAR BUTTON WITH NO EXTRA BONE LOSS. I USED A 2.5 MM DRILL BIT AND A SMALL CURETTE TO REMOVE THE POLYETHYLENE PEGS. THE KNEE WAS FLEXED UP. THE PREVIOUS TIBIAL INSERT WAS REMOVED USING A 1/2-INCH OSTEOTOME. ON GROSS INSPECTION, THERE WAS NO OBVIOUS SIGNS OF WEAR. I STARTED WITH REMOVAL OF THE FEMORAL COMPONENT. I USED AN OFFSET OSTEOTOME AND A 1/4-INCH CURVED OSTEOTOME TO WORK AROUND THE EDGES

  Patient problems: Failure of Implant

  MAUDE report 18192572 ↗
• InjuryJun 7, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE 59 Y/O MALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2020. APPROXIMATELY 2 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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. REVISION OP REPORT ON (B)(6) 2023: POSTOPERATIVE DIAGNOSIS: PROSTHETIC WEAR AND ARTHROFIBROSIS OF RIGHT TOTAL KNEE ARTHROPLASTY. THERE WAS WEAR ON THE POLYETHYLENE COMPONENT AND ON THE TIBIAL INSERT COMPONENT OF THE RIGHT TOTAL KNEE ARTHROPLASTY. THERE WAS ARTHROFIBROSIS PRESENT WITHIN THE JOINT. FINDINGS: THE PATIENT WAS NOTED TO HAVE A RIGHT TOTAL KNEE ARTHROPLASTY. THERE WAS WEAR ON THE POLYETHYLENE COMPONENT AND ON THE TIBIAL INSERT COMPONENT OF THE RIGHT KNEE. THERE WAS ARTHROFIBROSIS PRESENT WITHIN THE JOINT. THE PATIENT WAS TAKEN FROM THE OPERATING ROOM TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS WERE ENCOUNTERED.

  Patient problems: Ambulation or Postural Difficulties; Arthrofibrosis; Failure of Implant; Fibrosis; Inflammation; Joint Laxity; Joint effusion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 17083301 ↗
• InjuryNov 1, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL BRIEF, IN 2017, PATIENT HAD HIS KNEE REPLACED USING A KNEE DEVICE FROM EXACTECH. PATIENT NEEDED TO REPLACE HIS KNEE DEVICE IN 2020, INCURRING COSTS AT PERSONAL EXPENSE. IN MARCH 2022, PATIENT RECEIVED A NOTICE FROM EXACTECH, INDICATING A RECALL ON THE ORIGINAL KNEE DEVICE MADE BY EXACTECH. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 15710136 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL TEAM, THIS MALE PATIENT COMPLAINTS OF PAIN AND ACHES IN RIGHT LEG, LIMPING. HE SAID HE HAS BEEN TELLING HIS SURGEON THAT FOR ABOUT A YEAR. PATIENT HAD X-RAYS DONE ABOUT A MONTH AGO AND SURGEON SAID THEY WERE FINE. PATIENT IS NOW WITH RECALL CONCERNED THAT SURGEON MAY NOT HAVE BEEN SEARCHING FOR THE RIGHT THING AND HE IS GOING TO SCHEDULE AN APPOINTMENT WITH HIS SURGEON FOR FOLLOW-UP. PATIENT ALSO SPOKE TO AN ATTORNEY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 13969325 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, PATIENT CAME TO OFFICE WITH SWOLLEN KNEE, PERIPROSTHETIC INFECTION. LINER EXCHANGED.

  Patient problems: Bacterial Infection

  MAUDE report 9538062 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171045. One submission often covers many models, so check the product and lot details in each record.

• Z-0585-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-