Truliant 02-022-44-3511Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862305190), received between Apr 27, 2023 and Oct 16, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DURING REVIEW OF THE PATIENT'S PREVIOUS REVISION (REFER TO REPORT NUMBER: 1038671-2024-03993), IT WAS DISCOVERED THE PATIENT UNDERWENT A SECOND KNEE REVISION SURGERY; REASON UNKNOWN. NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20464975 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A QUAD RUPTURE AND ALSO AN INCIDENTAL POLY EXCHANGE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Rupture

  MAUDE report 19727197 ↗
• InjuryApr 15, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN (B)(6) 2020, THEN APPROXIMATELY 2 YEARS LATER HAD A KNEE REVISION SURGERY ON (B)(6) 2022. THE DATE OF IMPLANT IS NOT REPORTED/ THE DEVICES ARE NOT REPORTED/ THERE IS NO INFORMATION ON THE WHICH KNEE WAS REPLACED OR REVISED. THERE IS NO OTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information; Scar Tissue

  MAUDE report 19104755 ↗
• InjuryFeb 22, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2020. APPROXIMATELY 2 YEARS AND 9 MONTH AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. 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) 2023. DIAGNOSIS: FAILED LEFT KNEE SECONDARY TO PREMATURE POLYETHYLENE WEAR AS WELL AS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THERE WAS EARLY POLYETHYLENE SYNOVITIS WITH PARTICULATE DEBRIS IN THE GUTTERS. THERE WAS FLATTENING AND EARLY WEAR ON THE LATERAL FACET. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18758135 ↗
• InjuryJan 11, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT 1.5 YEARS POST OP INITIAL RIGHT TKA, THIS PATIENT HAD A REVISION. THE 11MM PSC POLY WAS EXCHANGED FOR A 17MM PSC POLY DURING A POLY SWAP AND QUAD TENDON REPAIR PROCEDURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS OR PHOTOS PROVIDED, UNABLE TO OBTAIN. NO PRODUCT RETURN; AGAINST POLICY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18498250 ↗
• InjuryJun 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED. SURGEON PREFORMED A POLY SWAP, POLY WAS SWAPPED TO TRULIANT PSC TIBIAL INSERT SZ 3.5 X 15MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS OR PHOTOS PROVIDED, UNABLE TO OBTAIN. NO PRODUCT RETURN. NO REASON REPORTED FOR PRODUCT NOT BEING RETURNED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17165327 ↗
• InjuryApr 27, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL NOTIFICATION: A MALE PATIENT HAD AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2020, AND THEN UNDERWENT REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 2 YEARS AFTER IMPLANT PROCEDURE. REVISION SURGERY OPERATIVE REPORT OF (B)(6) 2022-FAILED RIGHT KNEE ARTHROPLASTY SECONDARY TO ASEPTIC LOOSENING AND POLY WEAR. OBESE BMI 37-THE DURATION OF THE PROCEDURE WAS INCREASED BY APPROXIMATELY 40%, DUE TO PATIENT SIZE, THIS INCREASED COMPLEXITY AND DIFFICULTY OF SURGICAL PROCEDURE. FINDINGS: INTRAOPERATIVE FINDINGS CONFIRMED THE RADIOGRAPHIC AND CLINICAL FINDINGS OF FAILURE OF THE KNEE ARTHROPLASTY SECONDARY TO ASEPTIC LOOSENING (FEMORAL COMPONENT, TIBIAL COMPONENT WELL FIXED) CHARACTERIZED BY NO BONY INGROWTH ON THE BACKSIDE OF THE FEMORAL COMPONENT WITH EASY COMPONENT REMOVAL. ABUNDANT POLYETHYLENE PARTICLES THROUGHOUT THE KNEE. POLY WAS REMOVED AND INSPECTED, THERE WAS NOTABLE WEAR ON THE TIBIAL POST. THE PATELLA WAS FOUND TO BE WELL-FIXED AND WITHOUT SIGNIFICANT SURFACE DAMAGE, DELAMINATION OR PITTING; IT WAS DECIDED TO PLACE A NEW BUTTON. A DRESSING AND WRAP WERE APPLIED, THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT

  Patient problems: Failure of Implant; Implant Pain; Scar Tissue

  MAUDE report 16824514 ↗