Truliant 02-022-44-4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862305305), received between May 11, 2022 and Oct 16, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Unstable; Unstable

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED. POLY WAS SWAPPED OUT OF A LARGER ONE (PSC 4, 15MM). PATIENT CONTACTED SURGEON REPORTING INSTABILITY, SO THE POLY WAS SWAPPED OUT. THE POLY PREVIOUSLY IN PATIENT WAS ON THE RECALL LIST. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 20466087 ↗
• InjurySep 12, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ONGOING PERIPROSTHETIC INFECTION. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Ankylosis; Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20204815 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 16 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Insufficient Information; Swelling/ Edema

  MAUDE report 19488105 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL TKA, THE PATIENT WAS REVISED DUE TO PATELLA PAIN. A PARTIAL PATELLECTOMY WAS PERFORMED AND NEW POLY OF SAME SIZE WAS IMPLANTED. THERE WAS NO ISSUES WITH SURGERY. PHOTOS AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Implant Pain; Pain

  MAUDE report 18650940 ↗
• InjuryJul 7, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2019. THEY UNDERWENT REVISION SURGERY ON 07-DEC-2021, APPROXIMATELY 2 YEARS 1 MONTH AFTER THEIR PRIMARY PROCEDURE DUE TO ACUTE PAIN, COMPONENT LOOSENING, AND CONSISTENT INSTABILITY. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Pain

  MAUDE report 17279734 ↗
• InjuryJun 27, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THE PATIENT HAD A LEFT KNEE TKA INITIAL ON (B)(6) 2020. EXPLANT DATE HAS NOT BEEN SCHEDULED. THE PATIENT HAS PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. 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; Discomfort; Implant Pain; Pain

  MAUDE report 17208160 ↗
• InjuryFeb 23, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  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: Bacterial Infection; Implant Pain; Joint effusion; Pain

  MAUDE report 16432517 ↗
• InjuryOct 4, 2022Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT A MALE PATIENT, HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, AND IS SCHEDULED FOR A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS POST OP FOR REASONS UNKNOWN. NO ADDITIONAL INFORMATION.

  Patient problems: Discomfort; Failure of Implant; Joint Laxity; Joint effusion; Muscle Weakness/Atrophy; Pain; Scar Tissue

  MAUDE report 15535780 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY FOUR MONTHS POST INITIAL TKA, THIS PATIENT PRESENTED TO ED ON (B)(6) 2019 WITH RIGHT INFECTED KNEE. PATIENT TAKEN TO OR ON (B)(6) 2019 FOR EXPLANT OF TKA AND PLACEMENT OF ANTIBIOTIC SPACER. EVENT IS ONGOING. PER CLINICAL STUDY CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Bacterial Infection

  MAUDE report 14361656 ↗