Truliant 02-029-19-1200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862584175), received between Feb 18, 2021 and Jul 22, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2022Break; Break

  IT WAS REPORTED THAT THE WELDING OF THE BACKSLAP CAME UNDONE AND THE TOOL CAN'T FUNCTION PROPERLY. NO PIECES FELL OFF THE INSTRUMENT WHEN THE INSTRUMENT BROKE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15087771 ↗
• MalfunctionOct 14, 2021Break; Break

  AS REPORTED, THE SURGEON WENT TO REMOVE THE FEMORAL TRIAL FROM THE PATIENT'S FEMUR USING THE FEMORAL SLAP HAMMER ATTACHMENT. AFTER THE SECOND SLAP TO TRY TO REMOVE THE FEMUR TRIAL THE INSTRUMENT BROKE. THE SURGEON TRIED TO USE IT AFTER IT HAD BROKEN, AND IT WOULD NOT REMOVE THE FEMUR FROM THE BONE. THE SURGEON USED AN OSTEOTOME TO REMOVE THE TRAIL. NO PIECES WERE LEFT IN THE PATIENT. THE SLAP HAMMER ATTACHMENT TIP BROKE DURING USE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE INSTRUMENT IS BEING SENT BACK TO EXACTECH AND A NEW ONE HAS BEEN ORDERED FOR REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636698 ↗
• InjuryFeb 18, 2021Break; Break

  AAS REPORTED, THE TRULIANT SLAP HAMMER ATTACHMENT BROKE DURING SURGERY ON A FEMALE PATIENT. THE SURGEON ATTACHED THE SLAP HAMMER TO REMOVE THE FEMORAL TRIAL AND DURING REMOVAL THE SLAP HAMMER TIP BROKE. THERE WERE NO PARTS OR PIECES THAT FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO GET THE TRAIL FEMUR OFF. THE INSTRUMENT IS BEING SENT BACK TO MANUFACTURER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11346446 ↗

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