Optetrak Logic 02-012-35-1513Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862180773), received between Nov 10, 2022 and May 17, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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

1 other recall cover devices cleared under the same FDA submission (K093360); 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-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19343271 ↗
• InjuryNov 10, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED A FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) APPROXIMATELY 5 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH PAIN AND SYNOVITIS. MRI DID NOT SHOW LOOSE COMPONENTS PER THE SURGEON. AGGRAVATED TISSUE WAS REMOVED, AND A NEW PS POLY WAS INSERTED. THERE WAS SOME LAXITY WITH THE SAME 13MM PS SO A 15MM INSERT WAS CHOSEN. GOOD ROM AND STABILITY WERE ACHIEVED. THE SURGEON NOTED SIGNIFICANT WEAR. PATIENT LEFT IN STABLE CONDITION.

  Patient problems: Implant Pain; Inflammation; Joint Laxity; Pain; Synovitis

  MAUDE report 15777560 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093360. One submission often covers many models, so check the product and lot details in each record.

• Z-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ