Truliant CCRecalls & reported problems across all models

We found 17 models of Truliant CC by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2024 and Mar 31, 2026 — classified as 1 death, 23 injuries.

The most frequently reported specific device problem is “Naturally Worn” (18 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Truliant CC recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 21, 2023Open, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0583-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported Truliant CC problems

Truliant CC models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Truliant CC 02-012-65-3013

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 recall1 report
• Truliant CC 02-012-65-4013

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• Truliant CC 02-010-06-0240

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• Truliant CC 02-012-65-2015

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• Truliant CC 02-012-65-2021

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 death2 reports
• Truliant CC 02-012-65-3011

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• Truliant CC 02-012-65-3019

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• Truliant CC 02-010-06-0220

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Truliant CC 02-010-06-0350

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Truliant CC 02-012-65-2013

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Truliant CC 02-012-65-4011

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Truliant CC 02-012-65-4019

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Truliant CC 02-012-65-4025

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Truliant CC 02-012-65-5011

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Truliant CC 02-012-65-5013

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Truliant CC 02-012-65-5015

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Truliant CC 02-012-65-5019

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report

Recent Truliant CC adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE ON A LEFT TKA, A POLY-TO-TIBIAL TRAY MISMATCH WAS LEFT UNCORRECTED: A SIZE 2 CC POLY WITH A 2.5F/3T TIBIAL TRAY. DURING THE REVISION, A 2.5F/3T TIBIAL TRAY WAS IMPLANTED WITH A 14MM O.D. X 25MM LENGTH STEM, WITH THE PLAN FOR A LEFT 2.5 PS FEMORAL COMPONENT. AFTER THE TIBIA WAS CEMENTED, THE FEMORAL COMPONENT WAS IMPLANTED WITH CEMENT. AFTER HOLDING THE FEMORAL COMPONENT TO THE FEMUR FOR ROUGHLY 10 MINUTES TO ENSURE THE CEMENT HAD SET, HE LET GO AND REALIZED THE FEMORAL COMPONENT WAS NOT STAYING. THE SURGEON DECIDED TO GO TO A CC FEMUR WITH A STEM. A SIZE 2 CC FEMUR WITH A 17MM CC TIBIAL INSERT. THEY CEMENTED A LEFT SIZE 2 CC FEMUR WITH A 14 MM O.D. X 120MM LENGTH STEM. THEY THEN INSERTED THE 17MM CC TIBIAL INSERT AND REALIZED A LARGER INSERT WAS NEEDED, THUS REMOVING AND INSERTING A 21MM CC TIBIAL INSERT WITH THE LOCKING SCREW GOING THROUGH THE TIBIAL INSERT, THE TIBIAL TRAY, AND THE STEM. THE FINAL CONSTRUCT IMPLANTED IN THE PATIENT WAS A LEFT SIZE 2 CC FEMORAL COMPONENT WITH A 14 MM O.D. X 120MM LENGTH STEM ON THE FEMORAL SIDE. ON THE TIBIAL SIZE, THERE IS SIZE 2 21MM CC TIBIAL INSERT WITH A SIZE 2.5F/3T TIBIAL TRAY, AND A 14MM O.D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748518 ↗
• InjuryDec 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. THERE WAS MILD OSTEOLYSIS PRESENT AND THE PATELLA EXHIBITED SIGNIFICANT WEAR ALONG LATERAL TRACKING PATH. THE TIBIAL INSERT ALSO HAD MINIMAL WEAR ON MEDIAL AND LATERAL ARTICULAR SURFACE. FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. AS A RESULT, THE TIBIAL AND FEMORAL COMPONENTS WERE RETAINED WHILE THE PATELLA AND TIBIAL INSERT COMPONENTS WERE REPLACED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Osteolysis

  MAUDE report 23830944 ↗
• InjuryNov 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 95 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, FEMORAL KNEE DEBONDING/LOOSENING, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Discomfort; Pain

  MAUDE report 23598430 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. DURING THE PROCEDURE, IT WAS NOTED THAT AN INTRA-OPERATIVE DISTAL FEMUR FRACTURE OCCURRED WHILE CEMENTING ON THE FINAL FEMORAL COMPONENT. IT WAS MENTIONED THAT THE ANTERIOR FLANGE OF THE IMPLANT WAS CAUGHT ON THE ANTERIOR CORTEX, RESULTING IN A FEMORAL SPLIT OF APPROXIMATELY TWO (2) CENTIMETERS. THE FRACTURE WAS FIXED USING TWO SUTURE CERCLAGE. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 22777284 ↗
• InjuryMay 28, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEARS POST INITIAL OPERATION. SUBSEQUENTLY, THE PATIENT PRESENTED TO SURGEON WITH A LOOSE TIBIA AND PATELLA. SURGEON REMOVED A 38 PATELLA, A SIZE 4F/3T TIBIAL TRAY AND A 14 X 25 TIBIAL STEM. ALSO THE LINER WAS A SIZE 4/13MM CONSTRAINED PS INSERT. THE SURGEON REVISED TO A THE TIBIA TO A 4F/3T WITH A 16 X 80 STEM. THE PATELLA WAS REVISED TO A 41MM THREE PEG PATELLA. A 32 TIBIAL METAPHYSEAL CONE AND A. 4/19MM CONSTRAINED INSERT. THE PATIENT IS EXTREMELY ACTIVE AND DOES MANUAL LABOR FOR WORK. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22097564 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 97 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE AND EXPERIENCED AN INTRAOPERATIVE COMPLICATION. INITIAL AND REVISION OPERATIVE NOTES WERE PROVIDED. DURING IMPACTION OF THE REVISION FEMORAL COMPONENTS, THE SURGEON NOTED THAT THE FEMORAL CONDYLE MEDIALLY CRACKED AND WAS STABILIZED WITH A PIN. NO OTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM WITHOUT DIFFICULTY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 21687885 ↗
• InjuryMar 24, 2025Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 97 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, FEMORAL COMPONENT LOOSENING, INCREASING PAIN, MARKED STIFFNESS AND DECREASED RANGE OF MOTION. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. FINDINGS INDICATED GROSS LOOSENING FEMORAL COMPONENT; MARKED ARTHROFIBROSIS WITHOUT EVIDENCE OF INFECTION; OSTEOPENIA WITH SIGNIFICANT PROXIMAL FEMORAL BONE THINNING; SUBSIDENCE OF THE PATELLAR COMPONENT WITH AGGRESSIVE BONE OVERGROWTH AND PATELLA BAJA. THE SURGEON PERFORMED A REVISION OF THE FEMORAL COMPONENT AND TIBIAL POLYETHYLENE. THE SURGEON NOTED THAT THE FEMORAL CONDYLE MEDIALLY CRACKED DURING IMPACTION OF THE REVISION FEMORAL COMPONENTS, WHICH WAS THEN STABILIZED WITH A PIN. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM WITHOUT DIFFICULTY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification; Fibrosis; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Scar Tissue

  MAUDE report 21679761 ↗
• InjuryFeb 24, 2025Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL NOTIFICATION APPROXIMATELY 24 MONTHS AFTER A RIGHT KNEE REVISION SURGERY, THE PATIENT HAS EXPERIENCED PAIN IN HIS RIGHT KNEE. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-65-5015 - LOGIC CC TIB INSERT SIZE 5, 15MM SERIAL: (B)(6), 510K: K150890, UDI: (B)(4), PRODUCT CODE: JWH, X-RAY: NO, OPERATIVE NOTES: NO. CONCOMITANT DEVICES:

  Patient problems: Implant Pain; Pain

  MAUDE report 21453811 ↗
• InjuryDec 26, 2024Naturally Worn; Naturally Worn

  PER A REPORT FROM THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT KNEE IMPLANTED. THE PATIENT HAD TWO REVISIONS OF THE RIGHT KNEE. OP REPORT PRE & POST OP DIAGNOSIS: FAILED TOTAL RIGHT KNEE REPLACEMENT. INDICATIONS: PATIENT HAD SEVERE PAIN DUE TO FAILED ASEPTIC LOOSENING OF TOTAL RIGHT KNEE REPLACEMENT. PT HAS FAILED CONSERVATIVE TREATMENT AND WISHED TO UNDERGO OPERATIVE INTERVENTION. RISKS, BENEFITS, AND ALTERNATIVES DISCUSSED WITH PATIENT. DESPITE POTENTIAL RISKS, THEY WISHED TO PROCEED WITH THE OPERATIVE INTERVENTION. INTRAOPERATIVE FINDINGS: LOOSE FEMORAL IMPLANT - REMOVED EASILY WITH MINIMAL BONE LOSS BUT CONCERNED FOR BONE QUALITY DISTAL FEMUR. I ELECTED TO SUE FEMORAL CONE. TIBIAL IMPLANT WAS VERY SOLID AND WELL FIXED - BACKSLAP DEVICE AND OSTEOTOMES WERE USED BUT STEM WOULD NOT BUDGE - CORTICAL WINDOW DISTAL TO THE STEM ALLOWED ME TO HIT THE STEM TIP AND KNOCK IT OUT RETROGRADE.

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

  MAUDE report 21021297 ↗
• InjuryDec 26, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  APPROXIMATELY TWO-YEAR POST INITIAL LEFT SIDE TKA, THE 86 Y/O FEMALE PATIENT HAD A REVISION. PREOPERATIVE DIAGNOSIS-FAILED LEFT KNEE ARTHROPLASTY DUE TO INSTABILITY, POOR MOTION, PAIN AND PATELLAR COMPONENT LOOSENING. PATIENT WAS REVISED TO SAME COMPANY DEVICES. THE FEMORAL COMPONENT ROTATION WAS OKAY, MATCHING THE EPICONDYLAR AXIS. THERE WAS DENSE SCAR THROUGHOUT THE KNEE IN EXTENSION WITH MEDIAL LIFTOFF OF 5MM WITH VALGUS STRESS. BOTH THE FEMORAL AND TIBIAL COMPONENTS APPEARED TO BE APPROPRIATELY SIZED AND IN APPROPRIATE ROTATION. THERE WAS NO EVIDENCE OF LOOSENING OF EITHER THE FEMORAL OR TIBIAL COMPONENTS. THE JOINT FLUID WAS CLEAR AND YELLOW. THERE WAS NO EVIDENCE OF DEEP INFECTION. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. THERE IS NO OTHER INFORMATION AVAILABLE. RIGHT KNEE REVISION REPORTED UNDER MDR # 1038671-2023-00338.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 21019644 ↗
• InjuryOct 21, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MDL NO. (B)(4)). PATIENT ID: (B)(6) + LEFT KNEE. (B)(6) 2024: ATTACHED LEGAL SHORT FORM. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), AND PENDING IN THE (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE. AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY 4.1 YEARS POST INITIAL LEFT TKA, THE 59 YEAR OLD MALE PATIENT HAD A REVISION DUE TO PREMATURE POLY WEAR AND POLY RECALL WITH OSTEOLYSIS AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. DURING REVISION SURGERY, IT WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WERE FOUND TO BE GROSSLY LOOSE FEMORAL AND TIBIAL COMPONENTS THAT WERE EASI

  Patient problems: Failure of Implant; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20494596 ↗
• InjuryAug 20, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 41 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20001891 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD A PREVIOUS REVISION ON (B)(6) 2024; REASON NOT REPORTED. THE PATIENT FELL AND SPLIT OPEN WOUND AND UNDERWENT AN INCISION AND DRAINAGE WITH POLY SWAP ON (B)(6) 2024. 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Wound Dehiscence

  MAUDE report 19973386 ↗
• InjuryJun 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A TRULIANT DEVICE ON THE LEFT KNEE, 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: Insufficient Information

  MAUDE report 19619632 ↗
• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE RIGHT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: JOINT PAIN, JOINT SWELLING AND STIFFNESS. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19611154 ↗

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