Truliant 02-020-11-0235Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10885862314444), received between Feb 17, 2021 and Jan 3, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (15 reports).

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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 30 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, INSTABILITY, SCAR TISSUE, SYNOVITIS, JOINT EFFUSION, JOINT LAXITY, INFLAMMATION, SWELLING/ EDEMA, AND PAIN. 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.

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

  MAUDE report 21068239 ↗
• InjuryDec 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 54 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND POLY RECALL WITH SUBSEQUENT LOOSENING OF FEMORAL COMPONENT. PATIENT EXPERIENCED SCAR TISSUE, OSTEOLYSIS AND FAILURE OF IMPLANT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Scar Tissue

  MAUDE report 21020589 ↗
• InjuryDec 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 60 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR AND LOOSENING OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Scar Tissue

  MAUDE report 20914433 ↗
• InjuryAug 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 72 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 3 YEARS 2 MONTHS POST OP. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: CHAIN OF COMMAND. DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Osteolysis; Pain

  MAUDE report 19932176 ↗
• InjuryFeb 29, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL LEFT TKA, THE 48 Y/O FEMALE PATIENT COMPLAINED OF PAIN. THE PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Failure of Implant; Joint effusion; Osteolysis; Pain

  MAUDE report 18812704 ↗
• InjuryOct 12, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL LEFT TKA, THE 55 Y/O MALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY. DUE TO RECALL SURGEON USED COMPETITOR'S DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17926573 ↗
• InjurySep 20, 2023Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 2 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020. 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. THE PATIENT HAS FILED A COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN

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

  MAUDE report 17783027 ↗
• InjurySep 13, 2023Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL BRIEF, DESPITE EXPERIENCING CONTINUOUS PAIN AND INSTABILITY IN HER RIGHT KNEE, PATIENT WAS FORCED TO SCHEDULE A TOTAL REPLACEMENT SURGERY FOR HER LEFT KNEE AT THE ADVICE OF HER SURGEON. THE SURGERY TO IMPLANT THE EXACTECH TOTAL KNEE REPLACEMENT SYSTEM WAS PERFORMED ON (B)(6), 2021. PATIENT AGAIN UNDERWENT EXTENSIVE PHYSICAL REHABILITATION IN THE MONTHS FOLLOWING HER SECOND TOTAL KNEE REPLACEMENT SURGERY AND CONTINUED TO EXPERIENCE EXTENSIVE PAIN AND INSTABILITY, PARTICULARLY IN HER RIGHT KNEE. ON (B)(6) 2022, PATIENT RECEIVED A PHONE CALL FROM HER SURGEON WHO EXPLAINED THAT BOTH OF HER TOTAL KNEE REPLACEMENTS SYSTEMS WERE RECALLED AND INFORMED HER THAT BOTH OF HER KNEES WOULD NEED TO BE REPLACED AGAIN. PATIENT RECEIVED A LETTER FROM THE SOUTHERN JOINT REPLACEMENT INSTITUTE ON (B)(6), 2022, WHICH PROVIDED WRITTEN NOTICE THAT SHE RECEIVED DEFECTIVE PARTS FROM AN EXACTECH KNEE REPLACEMENT SYSTEM AND THAT THE COMPONENTS WERE BEING RECALLED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE 51 Y/O FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY. DUE TO RECALL SURGEON USED COMPETITORS FOR REVISION. THERE WAS NO BREAKAGE

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Failure of Implant; Pain

  MAUDE report 17734036 ↗
• InjuryMay 8, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION A FEMALE PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND THEN APPROXIMATELY 11 MONTHS LATER UNDERWENT A REVISION SURGERY FOR LOOSENING. REVISION OPERATIVE REPORT OF(B)(6) 2022 FOR FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND RECALLED POLYETHYLENE INSERT. THE PATIENT HAD PROGRESSIVE PAIN WITH ACTIVITIES AND SWELLING, WHICH CONTINUED TO GET WORSE. RADIOGRAPHS SHOWED A DEVELOPING RADIOLUCENCY UNDER THE FEMORAL COMPONENT. NEGATIVE FOR INFECTION. 1ML OF INFLAMMATORY FLUID DRAWN, THERE WAS NO PURULENCE OR SIGN OF INFECTION. THE PATELLAR BUTTON WAS IN GOOD CONDITION AND WELL FIXED, IT WAS RETAINED. THE TIBIAL INSERT WAS REMOVED AND DID NOT SHOW SIGNS OF DELAMINATION OR WEAR. THE FEMUR DISIMPACTED WITHOUT DIFFICULTY. STERILE DRESSINGS WERE APPLIED, THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THE IMPLANT WAS KEPT FOR CHAIN OF CUSTODY. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16885794 ↗
• InjuryMay 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THIS PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019 AND THEN APPROXIMATELY 3 YEARS, 4 MONTHS, AFTER INITIAL IMPLANT, UNDERWENT A LEFT KNEE REVISION FOR FEMORAL LOOSENING. OPERATIVE REPORT OF (B)(6) 2023-REVISION OF LEFT KNEE FAILED TOTAL KNEE ARTHROPLASTY DUE TO LOOSENING. IMPLANT RECALL. OPERATIVE FINDINGS- LOOSE FEMORAL COMPONENT WITH DEBONDING OF THE METAL/CEMENT INTERFACE. WELL FIXED TIBIAL COMPONENT. CHRONIC SYNOVITIS OF THE KNEE. NO COMPLICATIONS. PATIENT PRESENTED TO THE CLINIC WITH ONGOING LEFT KNEE PAIN. DRESSINGS WERE PLACED AND THE PATIENT WAS REVIVED FROM ANESTHETIC. PATIENT TO BE DISCHARGED TO HOME WHEN ALL CRITERIA ARE MET. ¿ALL COMPONENTS REMOVED WERE HANDED OFF FOR CHAIN OF CUSTODY PER PATIENTS REQUEST.¿ THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 16879715 ↗
• InjuryNov 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL LEFT SIDE TKA, THE 54 Y/O FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD LOOSE FEMUR. PATIENT WAS REVISED TO COMPETITORS DEVICE DUE TO DEVICE RECALL. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTO RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE IMPLANTS.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Osteolysis; Pain; Unspecified Musculoskeletal problem

  MAUDE report 15877758 ↗
• InjuryNov 8, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL LEFT SIDE TKA, THE 42 Y/O MALE COMPLAINED OF PAIN. PATIENT HAD LOOSE FEMUR. PATIENT WAS NOT REVISED TO EXACTECH DEVICES DUE TO RECALL SURGEON USED COMPETITOR. THERE WAS NO BREAKAGE OF A DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15754571 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY 3 YEARS POST INITIAL RIGHT TKA, THIS FEMALE PATIENT IS ASKING TO BE COMPENSATED FOR PAIN AND SUFFERING. THERE IS NO INDICATION OF REVISION ON EITHER SIDE TO DATE.

  Patient problems: Pain

  MAUDE report 13996690 ↗
• InjuryOct 25, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, PATIENT COMPLAINED OF STARTUP PAIN. THE MALE PATIENT WAS BROUGHT BACK FOR LEFT KNEE REVISION. THE INSERT WAS REMOVED. THE TIBIA WAS CHECKED AND FOUND TO BE WELL FIXED, FEMUR CHECKED AND WAS LOOSE. THE PATIENT RECEIVED A SIZE 3 LEFT CC FEMUR, 15X120 STEM, 17MM INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12689363 ↗
• InjuryAug 24, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2.5 YEARS POSTOP THE INITIAL LTKA, THE (B)(6) FEMALE PATIENT¿S FEMUR AND TIBIA WERE BOTH REVISED DUE TO LOOSENING. THE LINER WAS REMOVED, TIBIA FOUND TO BE LOOSE AND REMOVED, FEMUR WAS CHECKED AND FOUND TO BE LOOSE AS WELL. THE PATIENT RECEIVED A LOGIC CCK KNEE SYSTEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12362574 ↗
• InjuryFeb 17, 2021Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS POSTOP THE INITIAL TKA, THIS (B)(6) Y/O FEMALE PATIENT¿S LEFT KNEE WAS REVISED FOR LOOSENING OF THE FEMUR. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL RETURN.

  Patient problems: Failure of Implant

  MAUDE report 11339142 ↗