Truliant 02-022-51-4009Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862307750), received between Aug 18, 2022 and Aug 1, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0023-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryAug 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 22 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, WORSENING PAIN, SWELLING, MOTION RESTRICTION, DIFFICULTY WITH AMBULATION, AND DIFFICULTY PERFORMING SIMPLE ACTIVITIES OF DAILY LIVING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Ankylosis; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Joint Contracture; Pain; Swelling/ Edema

  MAUDE report 19883944 ↗
• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  AS REPORTED, A PATIENT'S LEFT KNEE WAS REVISED DUE TO RECURRENT SWELLING WITH A POSSIBILITY OF POLYETHYLENE WEAR DUE TO THE PREVIOUS RECALL. THE POLY WAS REMOVED AND REPLACED WITH A 9MM ACTIVIT-E CRC POLY. THE ORIGINAL POLY IMPLANT SHOWED NO REAL SIGNS OF ABNORMAL WEAR. THE REPORTED EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE REPORTED EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE PRODUCT IS NOT RETURNING. THE HOSPITAL TAKES THEM AFTER EXPLANTATION. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Swelling/ Edema

  MAUDE report 19660211 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 49 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19281389 ↗
• InjuryMar 3, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP THE INITIAL TKA, THIS MALE PATIENT WAS REVISED DUE WEAR. SURGEON NOTED SOME WEAR ON THE POSTERIOR MEDIAL EDGE, REPLACED POLY AND RESURFACING THE PATELLA. HE RELEASED THE PCL. HE STATED THAT THERE WAS A GOOD CHANCE THE PATELLA WAS CAUSING PAIN SO HE RESURFACED THE PATELLA. THE ORIGINAL SURGERY HE LEFT THE PATELLA ALONE. EXPLANT NOT AVAILABLE, HOSPITAL DOES NOT RELEASE TO THE REPS. PATIENT LEFT IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 16477933 ↗
• InjuryJan 4, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY THIRTEEN MONTHS POST INITIAL LEFT SIDE TKA, THE 58 Y/O FEMALE PATIENT WAS REVISED DUE TO INSTABILITY. A THICKER POLY WAS IMPLANTED; THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT IS AGAINST HOSPITAL POLICY. PATIENT MEDICAL HISTORY/INFORMATION IS NOT AVAILABLE/PROVIDED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16096007 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDIES, EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 66 YO MALE, HEIGHT: 73 IN, WHO HAD INITIAL IMPLANT ON THE RIGHT KNEE ON (B)(6) 2019, AND HAD A SPACER PLACED ON (B)(6) 2020, PRESENTED WITH INFLAMMATION TO THE RIGHT KNEE ON (B)(6) 2022. THEY UNDERWENT A REVISION OF THE SPACER ON (B)(6) 2022 AND A KNEE ASPIRATION FOR CULTURE. OUTCOME INDICATES CONTINUING. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

  Patient problems: Inflammation

  MAUDE report 15254387 ↗