Truliant 02-022-47-5013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862306593), received between Oct 18, 2023 and Oct 18, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2023Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2021. OVER THE NEXT SEVERAL MONTHS, THE PATIENT UNDERWENT PHYSICAL THERAPY SESSIONS AND FOLLOW UP APPOINTMENTS WITH THE SURGEON, AS WELL AS INJECTIONS TO HIS LEFT KNEE. APPROXIMATELY 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 TO REMOVE THE POLYETHYLENE, CAUSING THE INJURIES AND DAMAGES COMPLAINED OF. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: PAINFUL LEFT TOTAL KNEE, POLYETHYLENE WEAR. AT THE TIME OF SURGERY THERE WAS SOME MINOR WEAR OF THE POLYETHYLENE ON BOTH THE LATERAL AND MEDIAL TIBIAL SURFACES WITH SOME MORE SIGNIFICANT WEAR ALONG THE POSTERIOR MEDIAL CORNER OF THE POLYETHYLENE. THE FEMORAL AND TIBIAL COMPONENTS WERE INTACT. THE 13MM POLYETHYLENE WAS EXCHANGED FOR A NEW 15 MM POLYETHYLENE AND THE KNEE SHOWED EXCELLENT RANGE OF MOTION AND STABILITY. THE PATIENT WAS ALSO NOTED TO HAVE HEAVY SCAR TISSUE THROUGHOUT THE JOINT CAPSULE. THE SCAR TISSUE WAS D

  Patient problems: Failure of Implant; Joint effusion; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17958175 ↗