Truliant 02-020-11-0345Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862314574), received between Mar 2, 2021 and Apr 14, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 reports).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2020. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED ON (B)(6) 2023 DUE TO A LOOSE FEMUR. THE DOCTOR USED COMPETITOR'S IMPLANTS FOR THE REVISION DUE TO THE RECALL. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 16748264 ↗
• InjuryApr 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL RIGHT TKA, THE 58 Y/O MALE PATIENT COMPLAINED OF PAIN. PATIENT HAD 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. PHOTOS AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE RECALL PRODUCTS. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

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

  MAUDE report 16668448 ↗
• InjuryNov 8, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL RIGHT SIDE TKA, THE 62 Y/O MALE PATIENT COMPLAINED OF PAIN. PATIENT HAD LOOSE FEMUR. PATIENT WAS NOT REVISED TO EXACTECH DEVICES DUE TO RECALL SURGEON USED COMPETITORS IMPLANTS FOR REVISION. 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. PHOTO RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

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

  MAUDE report 15754632 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL TKA, THIS (B)(6) MALE PATIENT HAD A REVISION DUE TO SIGNIFICANT PAIN IN WEIGHT-BEARING AND MOVEMENT. THE SURGEON DIAGNOSIS FAILED RIGHT KNEE DUE TO INSTABILITY. THERE WAS NO RELATED TO BREAKAGE OF THE DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO SURGEON WANTED TO KEEP IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 13529054 ↗
• InjuryNov 8, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FIVE MONTHS POST INITIAL RTKA, THE (B)(6) Y/O MALE PATIENT HAD A REVISION DUE TO A LOOSE TIBIA AND FEMUR. AFTER TRIALING THE FEMORAL COMPONENT, THE SURGICAL TEAM COULD NOT MATCH THE DEFINITIVE COMPONENTS TO MATCH STEM POSITION OF THE TRIAL, WHEN ALL SETTING WERE MIMICKED. THE 4MM OFFSET BUSHING OF THE TRIAL WAS IN POSITION 9, WHICH SURGEON SELECTED DURING CASE. LATER TRIALS WERE BUILT AND 4MM TRIAL FEMORAL BUSHING WAS SET TO 9. TRIALING WAS COMPLETED AND SURGEON INSTRUCTED US TO BUILD FINAL IMPLANTS. WHEN WE BUILT FEMUR WITH 4MM BUSHING SET TO 9 FINAL FEMUR DID NOT LOOK LIKE THE TRIAL COMPONENTS. BOTH WERE 4MM BUSHINGS SET TO 9 AND STEM POSITION WAS COMPLETELY DIFFERENT. AFTER MUCH DISCUSSION AND ANALYSIS FROM SURGEON AND OUR SALES TEAM WE DECIDED TO REPOSITION BUSHING UNTIL IT REPLICATED THE TRIAL IMPLANT. THIS EXERCISE CAUSED US TO MOVE FROM 9 TO SOMEWHERE BETWEEN 5-6. IT ALMOST SEEMED LIKE THE LASER ETCHINGS WERE MAL POSITIONED. COMPONENT WAS CEMENTED AND IMPLANTED SUCCESSFULLY, AND KNEE WAS VERY STABLE. BELOW WE ATTACHED DGF OF IMPLANTS BUT WE ARE NOT SURE WHICH 4MM BUSHING WAS THE PROBLEMATIC ONE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLL

  Patient problems: Failure of Implant

  MAUDE report 12771523 ↗
• InjuryMar 2, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2.5 YEARS POSTOP, THIS (B)(6) Y/O MALE PATIENT HAD A REVISION DONE BASED ON RIGHT FEMUR BEING LOOSE. THE DOCTOR ADVISED REP OF THIS REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS HOSPITAL RETAINS ALL RETRIEVALS.

  Patient problems: Failure of Implant

  MAUDE report 11398999 ↗

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-
• 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