Truliant 02-022-51-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862307651), received between Oct 14, 2019 and Jul 1, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 4 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19643309 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A 64 Y/O PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2019. PATIENT IS 5¿4¿ AND WEIGHS 185LBS CAME TO ED WITH LEFT KNEE PAIN ON (B)(6) 2019. FOUND TO HAVE QUADRICEPS TENDON RUPTURE ALONG WITH INFECTED LEFT TKA. ELEVATED LAB VALUES INDICATED INFECTION. TAKEN TO OR FOR I&D AND REVISION LEFT TKA. POSITIVE CULTURES FOR MRSE AND MSSA. STARTED ON IV ANTIBIOTICS FOR 6 WEEKS. THE PATIENT HAS A HISTORY OF PRIMARY OSTEOARTHRITIS, HYPERTENSION, AND CHRONIC RENAL FAILURE. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. 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 INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

  Patient problems: Bacterial Infection; Pain; Rupture; Staphylococcus Aureus

  MAUDE report 9184460 ↗