Optetrak 244-02-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862063809), received between Sep 29, 2022 and Nov 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K033883); 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.

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.

• InjuryNov 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED INSTABILITY. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 7 YEARS AND 6 MONTHS AFTER INITIAL IMPLANTATION. IT WAS LATER REPORTED THAT THE PATIENT'S FEMORAL COMPONENT HAD DEBONDED OR LOOSENED. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Aseptic loosening; Joint Laxity

  MAUDE report 23630698 ↗
• InjurySep 29, 2022Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST OP THE INITIAL LEFT TKA, THIS MALE PATIENT WAS REVISED DUE TO IMPLANT LOOSENING, BONE LOSS AND SIGNIFICANT SYNOVITIS. PATIENT HAD BEEN COMPLAINING OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN. FOLLOWING THE REVISION SURGERY, PLAINTIFF CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING, AND EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE WHICH LIMITS HIS ACTIVITIES AND IMPACTS HIS QUALITY OF LIFE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15503499 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants