Truliant 02-022-35-2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862304100), received between Mar 28, 2023 and Jun 29, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJun 29, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6)2019. THEY UNDERWENT RIGHT KNEE REVISION ON (B)(6)2022, APPROXIMATELY 3 YEARS 2 MONTHS AFTER THEIR INITIAL PROCEDURE. THE PATIENT CLAMS TO HAVE A FAILED RIGHT TOTAL KNEE ARTHROPLASTY WITH CONTRACTURE AND SEVERE PAIN. 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: Insufficient Information; Pain

  MAUDE report 17226866 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 54 YO FEMALE PATIENT WAS EXPERIENCING SYNOVITIS AND FIXED FLEXION DEFORMITY CAUSING CONSTANT PAIN AND SWELLING. BONE SCAN SHOWS INCREASED UPTAKE AROUND TIBIOFEMORAL AND PATELLAR COMPONENTS ON THE LEFT. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-2021. REVISION WAS RECOMMENDED AND SCHEDULED FOR (B)(6) 2021 BUT WAS DEFERRED BECAUSE HEMOGLOBIN A1C WAS >11 WHICH IS NOW BETTER CONTROLLED. THEREFORE, THE PATIENT WAS RESCHEDULED AND REVISED ON (B)(6) 2023. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

  Patient problems: Pain; Swelling/ Edema; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 16631585 ↗