Optetrak 246-03-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862064622), received between Apr 21, 2023 and Apr 21, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 16, 2026.

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.

• InjuryApr 21, 2023Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD AN INITIAL RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 4 MONTHS LATER THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022 DUE TO LOOSENING AND SIGNIFICANT SYNOVITIS. DURING THE REVISION SURGERY, THE SURGEON NOTED THAT THERE WAS "FOUND TO BE GROSSLY LOOSE" AND THAT THERE WAS "THERE WAS SIGNIFICANT SYNOVITIS NOTED AND THIS WAS DEBRIDED AND SENT FOR SYNOVIAL CULTURE.." THE SUBSEQUENT POST-OPERATIVE DIAGNOSIS CONFIRMED THAT THE PATIENT'S RIGHT TOTAL KNEE ARTHROPLASTY FAILED DUE TO SIGNIFICANT LOOSENING, WHICH IS RELATED TO THE FAILURE IN THE POLYETHYLENE. 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.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Erosion; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16783521 ↗

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 Inser
• 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