Truliant 02-020-11-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862314451), received between Mar 3, 2020 and May 14, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED OSTEOLYSIS, POLYETHYLENE LINER WEAR AND LOOSENING OF THE FEMORAL COMPONENT. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 4 YEARS AND 8 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 25174984 ↗
• InjuryDec 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND FEMORAL LOOSENING. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION 5 YEARS AND 11 MONTHS AFTER INITIAL IMPLANTATION. PROVIDED IMAGES OF THE TIBIAL INSERT OF WEAR. PROVIDED IMAGES OF THE PATELLAR COMPONENT SHOW SIGNS OF WEAR AND FRACTURE. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE. THIS IS REPORT 2 OF 3 FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 23866648 ↗
• InjuryMar 7, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PREMATURE POLYETHYLENE WEAR FROM RECALLED POLYETHYLENE INSERT, ASEPTIC LOOSENING OF FEMORAL AND PATELLAR COMPONENTS. 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; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21552208 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 26 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Inflammation; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21277733 ↗
• InjuryOct 10, 2024Unstable; 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 57 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20418036 ↗
• InjuryOct 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MDL NO. 3044). 10/8/24: ADDITIONAL INFORMATION RECEIVED IN INBOX ON 10/7/24. ATTACHED EMAIL, INITIAL OP REPORT/PRODUCT ID, AND REVISION OP REPORT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED CONTINUED PAIN AFTER LEFT TOTAL KNEE ARTHROPLASTY DUE TO MALROTATION OVER SIZE COMPONENTS. DESCRIPTION OF PROCEDURE: PATIENT IS A VERY PLEASANT 57-YEAR-OLD FEMALE WHO UNDERWENT AN INDEX LEFT TOTAL KNEE ARTHROPLASTY APPROXIMATELY ONE YEAR AGO. SHE CAME TO ME FOR EVALUATION OF CONTINUED PAIN. SHE WAS WORKED UP FOR PERIPROSTHETIC INFECTION, ASEPTIC LOOSENING, POLYETHYLENE WEAR, MALROTATION. THROUGHOUT THE ENTIRE WORKUP EVERYTHING WAS NEGATIVE BUT WAS NOTED THAT THE PATIENT HAD OVERHANG OF THE TIBIAL COMPONENT WITH SLIGHT VARUS MALALIGNMENT AND MOST LIKELY INTERNAL ROTATION OF THE FEMORAL COMPONENT INDUCING PAIN AND LATERAL PATELLAR SUBLUXATION AND TILT. ONCE THE KNEE WAS FLEXED UP I WAS ABLE TO REMOVE THE POLYETHYLENE LINER INSERT WITH EASE. I THEN EXPOSED THE FEMUR AND BEGAN INITIALLY TO USE A QUARTER-INCH OSTEOTOME TO BREAK THE CEMENT MANTLE INTERFACE. IT BECAME IMMEDIATELY OBVIOUS THAT THE FEMUR HAD COMPLETELY DEBONDED FRO

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Osteolysis; Pain

  MAUDE report 20416696 ↗
• InjuryJun 5, 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 54 Y/O MALE PATIENT COMPLAINED OF PAIN. THE PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND INSERT. PATIENT WAS REVISED TO EXACTECH DEVICES. 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 ATTACHED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO CHAIN OF COMMAND.

  Patient problems: Failure of Implant; Pain; Scar Tissue

  MAUDE report 19472465 ↗
• InjuryMay 19, 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, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2018 AND WAS IMPLANTED WITH AN EXACTECH TRULIANT DEVICE. THEY HAVE SINCE REPORTED SYMPTOMS INCLUDING PAIN, STIFFNESS, AND IMPAIRED MOBILITY. THERE IS NO INFORMATION REGARDING HAVING OR PLANNING TO HAVE REVISION SURGERY. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 16964308 ↗
• InjurySep 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL LEFT TKA, THIS 75 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. DUE TO RECALL SURGEON USED A COMPETITOR FOR REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING, DUE TO RECALL HOSPITAL WILL NOT RELEASE THE IMPLANTS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15494195 ↗
• InjuryAug 31, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP THE INITIAL LEFT TKA, THIS 53 Y/O FEMALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Inflammation; Joint effusion; Pain; Scar Tissue; Synovitis

  MAUDE report 15326561 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED APPROXIMATELY 14 MONTHS POSTOPERATIVE INITIAL LEFT TKA THIS (B)(6) Y/O FEMALE PATIENT¿S KNEE WAS DETERMINED TO HAVE A FAILED COMPONENT. THE SURGEON OPENED THE JOINT IN STANDARD FASHION AND DECIDED TO TAKE EVERYTHING OUT AND IMPLANTED A COMPETITOR¿S TKA. THE JOINT WAS CLOSED IN STANDARD FASHION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING DUE TO HOSPITAL POLICY.

  Patient problems: No Information

  MAUDE report 9780621 ↗