Truliant 02-022-48-4509Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862306913), received between Jul 29, 2024 and Jul 29, 2024 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2024Naturally Worn; Naturally Worn

  13. PLAINTIFF (B)(6) IS A RESIDENT AND CITIZEN OF (B)(6). 73. ON (B)(6) 2019 PLAINTIFF (B)(6) UNDERWENT A LEFT TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING AN INSERT MADE OF POLYETHYLENE, SERIAL NUMBER (B)(6). PLAINTIFF¿S TOTAL KNEE REPLACEMENT SURGERY WAS PERFORMED AT THE LAFAYETTE SURGICAL SPECIALTY HOSPITAL IN LAFAYETTE, LOUISIANA 74. PLAINTIFF HAS NOT YET SCHEDULED A REVISION SURGERY OF HIS LEFT TOTAL KNEE REPLACEMENT. 77. AS A DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE AS DESCRIBED HEREIN, PLAINTIFF (B)(6) HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. 78. AS A FURTHER DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE, PLAINTIFF HAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Distress; Emotional Changes; Insufficient Information; Pain

  MAUDE report 19856261 ↗

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-