Truliant 02-029-19-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862523587), received between Jan 19, 2021 and Dec 23, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K170240, K171045, K181794); 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PLASTIC PART OF THE FEMUR IMPACTOR BROKE DURING SURGICAL USE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO SURGICAL DELAY OR PROLONGATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21001627 ↗
• MalfunctionAug 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, WHILE IMPACTING THE FINAL FEMORAL IMPLANT, THE IMPACTOR BROKE. THERE WAS A SLIGHT SURGICAL DELAY WHILE LOADING A SECONDARY IMPACTOR. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT DUE TO THE DELAY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN. A DEVICE IMAGE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018747 ↗
• MalfunctionAug 6, 2021Break; Fracture; Break; Fracture

  AS REPORTED, THE PIN PULLER (CAT# 02-029-90-4100) WAS USED TO REMOVE THE PINS OUT OF THE TIBIA. THE BONE QUALITY WAS VERY GOOD AND WHEN THE SURGEON TRIED TO REMOVE THE PIN, THE TIP OF THE PIN PULLER BROKE OFF. FURTHERMORE, THE FEM IMPACTOR (02-029-19-1000) WAS BROKEN ON IMPACTION WHEN WE WERE IMPACTING THE FINAL FEMUR IMPLANT ON. ONE OF THE SIDES OF THE IMPACTOR BROKE OFF. THE SURGERY WAS NOT AFFECTED BY THE BREAKAGE. WE HAD BACKUPS AND THE CASE WENT VERY WELL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287903 ↗
• MalfunctionJul 14, 2021Break; Break

  AS REPORTED, DURING SURGICAL USE, THE FEMORAL TRIAL WAS LOADED ONTO THE FEMORAL INSERT. AS THE SURGEON BEGAN TO IMPACT THE TRIAL INTO PLACE, THE CLAW CLAMP SIDE PIECE BROKE OFF OF THE INSERT. THE BROKEN PIECE WAS OBTAINED ON THE STERILE FIELD. THE SURGEON HAD TO USE THE SECONDARY IMPACTOR TO THEN INSERT THE IMPLANT LATER ON IN THE PROCEDURE. NO PIECES FELL INTO THE PATIENT. ALL PIECES WERE SET TO THE SIDE OF THE BACK TABLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170585 ↗
• MalfunctionJun 10, 2021Break; Break

  AS REPORTED, DURING THIS INITIAL LTKA, THE FEMORAL IMPLANT WAS LOADED ONTO THE FEMORAL INSERTER/IMPACTOR. AS THE SURGEON BEGAN TO IMPACT THE FEMORAL IMPLANT INTO PLACE THE CLAW CLAMP SIDE PIECE BROKE OFF OF THE INSERTER. THE BROKEN PIECE WAS OBTAINED ON THE STERILE FIELD. THE SURGEON THEN USED THE SECONDARY IMPACTOR TO COMPLETE THE IMPACTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979005 ↗
• MalfunctionMay 19, 2021Break; Break

  AS REPORTED, THE INSTRUMENT HAS BEEN BROKEN WHILE INSERTING THE FEMORAL COMPONENT. THERE WERE NO PARTS OR PIECES LEFT IN THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848056 ↗
• MalfunctionApr 16, 2021Break; Break

  AS REPORTED, DURING RIGHT TOTAL KNEE ARTHROPLASTY ON THIS (B)(6) Y/O MALE PATIENT, THE FEMORAL INSERTER WAS DAMAGED WHILE CEMENTING THE FEMORAL COMPONENT UPON IMPACTION OF THE FEMORAL COMPONENT. THE HARD LINER WAS DAMAGED AND A PIECE OF THE LINER BROKE OFF AND FLEW ACROSS THE ROOM AWAY FROM THE STERILE FIELD. NO HARM WAS DONE TO THE PATIENT AND THERE WAS NO SIGNIFICANT DELAY IN SURGERY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678883 ↗
• MalfunctionFeb 3, 2021Break; Break

  AS REPORTED, DURING AN INITIAL PROCEDURE, THE SURGEON WAS USING THE TRULIANT FEMORAL LOCKING CLAMP IMPACTOR TO IMPLANT THE PATIENT¿S FEMUR. WHILE IMPACTING THE CLAW ON THE LOCKING MECHANISM BROKE OFF. THE SURGEON USED THE SECONDARY FEMORAL IMPACTOR TO FINISH IMPACTING/IMPLANTING THE FEMUR. THE BROKEN INSTRUMENT WAS HANDED OFF THE STERILE FIELD AND WILL BE RETURNED. THE PATIENT LEFT THE OR STABLE. THERE WAS NO DELAY TO THE SURGERY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE FACILITY DID NOT PROVIDE SPECIFIC PATIENT INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11271910 ↗
• MalfunctionJan 19, 2021Break; Break

  AS REPORTED, THE DOCTOR FOUND THAT FEMORAL IMPACTOR WAS BROKEN AFTER HE COMPLETED SURGERY ON A FEMALE PATIENT. THERE WAS NO DELAY IN SURGERY AS IT WORKED WELL DURING THE SURGERY. IT WAS NOTED THAT THE DOCTOR SEEMED TO NOT PUT STRONG PRESSURE ON THE INSTRUMENT WHEN IMPACTING THE IMPLANT. THE BROKEN INSTRUMENT WAS NOTED AFTER CLOSING THE PATIENT. IT WAS REPORTED THERE WERE NO PARTS LEFT IN THE PATIENT AND THERE WAS NO DELAY TO SURGERY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11193280 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170240, K171045, K181794. 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-
• Z-0023-2022 · Aug 30, 2021 · Open, Classified
  TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR