Optetrak Logic 02-012-42-3008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862003386), received between Feb 18, 2025 and Feb 18, 2025 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K071738); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Naturally Worn; Naturally Worn

  AS REPORTED BY LEGAL BRIEF, ON (B)(6) 2013, PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA). EVENTUALLY, PATIENT BEGAN TO SUFFER FROM INCREASING PAIN, SWELLING, AND INSTABILITY IN HER LEFT KNEE, WHICH SUBSEQUENTLY BECAME INFECTED. ON (B)(6) 2017, PATIENT UNDERWENT REVISION OF HER LEFT OPTETRAK DEVICE. UPON EXPLANATION OF THE OPTETRAK DEVICE, PATIENT¿S SURGEON OBSERVED THAT THERE WERE SIGNS OF METAL-WEAR DEBRIS, AS WELL AS EVIDENCE OF MICROMOTION BETWEEN THE METAL AUGMENT AND THE TIBIAL TRAY. THE OPERATIVE SURGEON STATED HIS BELIEF THAT ¿THIS WAS THE CAUSE¿ OF THE INFECTION THAT NECESSITATED REVISION. NO ADDITIONAL INFORMATION.

  Patient problems: Joint Laxity; Medical device site infection; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21401721 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071738. One submission often covers many models, so check the product and lot details in each record.

• Z-0953-2013 · Feb 1, 2013 · Terminated
  Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
• Z-2234-2012 · Oct 17, 2011 · Terminated
  OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The