Truliant 02-022-35-2515Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862304223), received between May 25, 2023 and Aug 15, 2024 — classified as 3 injuries.

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

• InjuryAug 15, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 22 MONTHS AFTER A TOTAL LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED PAIN, SIGNIFICANT SCARRING, SWELLING, EFFUSION, INFLAMMATION, KNEE POPPING/CLUNKING, KNEE GIVING AWAY, DIFFICULTY WALKING, ANTALGIC GAIT, LATERAL FACET SYNDROME, ANXIETY AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Inflammation; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19997509 ↗
• InjuryJul 12, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN UTI. SURGICAL PROCEDURE 1) ARTHROTOMY WITH DRAINAGE AND ANTERIOR/POSTERIOR SYNOVECTOMIES INFECTED KNEE 2) EXCHANGE OF LEFT KNEE POLYMER INSERT 3) APPLICATION RESORBABLE ANTIBIOTIC BEARS LEFT KNEE JOINT.REVISED TO EXACTECH INSERT (3.5F/2.5T). HE WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection

  MAUDE report 17308222 ↗
• InjuryMay 25, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2019. FOLLOWING THE SURGERY, THE PATIENT BEGAN EXPERIENCING INCREASING PAIN, INSTABILITY, ACHING, POPPING, STIFFNESS, BUCKLING, WEAKNESS, AND SWELLING TO HER KNEES. IN (B)(6) 2021, THE PATIENT WAS DESCENDING A SET OF STAIRS WHEN HER KNEES GAVE OUT. SHE FELL DOWN THE STAIRS. SEVERAL MONTHS LATER, THE PATIENT SUFFERED ANOTHER FALL DUE TO WEAKNESS IN HER KNEES. ON (B)(6) 2023, THE PATIENT REPORTED THAT THE PAIN, WEAKNESS, AND POPPING IN HER KNEES HAD BECOME INCREASINGLY WORSE OVER THE PAST YEAR. THE PATIENT'S PHYSICIAN EXPLAINED THAT DUE TO ¿ONE OF THE PACKAGING LAYERS OF THE PLASTIC INSERT¿ BEING ¿OUT OF SPECIFICATION,¿ EARLY OXIDATION ¿CAN CAUSE THE PLASTIC TO WEAR OUT EARLIER THAN EXPECTED OR TO BECOME DAMAGED AFTER IT IS IMPLANTED.¿ WITH THE PATIENT'S CONTINUED SYMPTOMS OF KNEE PAIN, SWELLING, AND THE INABILITY TO BEAR WEIGHT, PLAINTIFF AGREED TO UNDERGO A RIGHT KNEE REVISION SURGERY FOLLOWED BY A LEFT KNEE REVISION SURGERY. PLAINTIFF WILL UNDERGO A LEFT TOTAL KNEE REPLACEMENT REVISION SURGERY TO REMOVE THE DEVICE FROM HER LEFT KNEE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILAB

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Emotional Changes; Implant Pain; Joint Laxity; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 17002993 ↗