Truliant 02-022-44-4509Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862305350), received between Jul 26, 2023 and Aug 21, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K171045); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Naturally Worn; Naturally Worn

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

  Patient problems: Insufficient Information

  MAUDE report 20022640 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION- OPERATIVE REPORT - POSTOPERATIVE DIAGNOSIS: CHONDROMALACIA LEFT PATELLA. HISTORY OF LEFT TKA COMPLICATED BY WOUND DEHISCENCE AND SUBSEQUENT INFECTION WAS TREATED WITH IRRIGATION DEBRIDEMENT AND LINER EXCHANGE. CONTINUED TO HAVE PERSISTENT PAIN AND DISCOMFORT DESPITE NO OBVIOUS OCCULT INFECTION OR CONTINUED INFECTION ACTIVE WITHIN THE KNEE. PAINFUL TKA, CHONDROMALACIA PATELLA. REMAINING FAT PAD WAS SCARRED AND WAS DEBRIDED AND THE PATELLA DEVOID OF SIGNIFICANT CARTILAGE AND SHOWED SIGNS OF INFLAMMATION. DEBRIDED SOFT TISSUE ALONG WITH THE PATELLAR TENDON AND LATERAL GUTTER WAS SENT TO PATHOLOGY AND PATHOLOGY DETERMINED THERE WAS NO EVIDENCE OF ACTIVE INFECTION WITH WELL LESS THAN 5 PMNS PER HIGH-POWERED FIELD NOTED. TIBIAL AND FEMORAL COMPONENTS WELL SEATED AND NO EVIDENCE OF LOOSENING OR OCCULT INFECTION. LEFT PATELLOFEMORAL ARTHROPLASTY. THE PATIENT WAS IMPLANTED WITH A COMPETITORS PATELLA COMPONENT. THE PATIENT WAS THEN BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 17398273 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION-POST OPERATIVE DIAGNOSIS: LEFT KNEE SEPTIC ARTHRITIS. LEFT KNEE POLY EXCHANGE/ ANTIBIOTIC BEADS. SIGNIFICANT TISSUE LOSS AT THE MOST INFERIOR ASPECT OF THE CAPSULE WAS NOTED AND THE PRIOR SUTURES WERE CUT AND EXCISED. THOROUGH DEBRIDEMENT OF EXTRA CAPSULAR TISSUE WAS WELL AS A THOROUGH SYNOVECTOMY AND DEBRIDEMENT OF THE INTRACAPSULAR TISSUE WAS PERFORMED USING ELECTROCAUTERY AS WELL AS A RONGEUR. THE POLYETHYLENE LINER WAS REMOVED AT THIS TIME AND DEBRIDEMENT OF THE POSTERIOR CAPSULES WAS PERFORMED. THE PATIENT WAS THEN BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 17397670 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION-OPERATIVE REPORT -POSTOPERATIVE DIAGNOSIS: LEFT KNEE WOUND DEHISCENCE. PROCEDURE PERFORMED: IRRIGATION AND DEBRIDEMENT OF THE LEFT KNEE WOUND WITH POLYETHYLENE LINER EXCHANGE. THE PATIENT WAS REVISED TO EXACTECH DEVICE. THE PATIENT WAS THEN AWOKEN FROM GENERAL ANESTHESIA, HAVING TOLERATED THE PROCEDURE WELL. THE PATIENT WAS THEN BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 17396630 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171045. One submission often covers many models, so check the product and lot details in each record.

• Z-0585-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-