Optetrak Logic 02-012-41-3535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862003201), received between Mar 6, 2023 and Apr 14, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

2 other recalls 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 16, 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.

• InjuryApr 14, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED JOINT EFFUSION, OSTEOLYSIS AND ASEPTIC LOOSENING. AS A RESULT, APPROXIMATELY SIX YEARS AND NINE MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. IT WAS NOTED THAT "THE INITIAL IMPRESSION WAS THAT THE IMPLANTS WERE FIXED, BUT THEY CAME OFF THE DISTAL FEMUR & PROXIMAL TIBIA WITHOUT MUCH EFFORT. THIS PATIENT HAD SEVERE OSTEOLYSIS OF THE BONE. THIS IS PARTICULARLY WEAR DEBRIS OSTEOLYSIS BECAUSE OF FAILURE OF THE MEDIAL ASPECT OF THE TIBIAL INSERT THAT THE POSTERIOR ASPECT OF THE MEDIAL PORTION OF THE TIBIAL INSERT WAS FRACTURED AND MORSELIZED. THE INSERT, HOWEVER, REMAINED WELL FIXED. THERE WAS NO EVIDENCE OF INFECTION. THERE WAS NO FRACTURE." PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Aseptic loosening; Joint effusion; Osteolysis

  MAUDE report 24875521 ↗
• InjuryMar 6, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TWELVE YEARS POST INITIAL BILATERAL TKA, PATIENT LEFT KNEE WAS REVISED DUE TO PAIN. COMPONENTS WERE WELL FIXED. THE INSERT WAS FOUND TO HAVE AN UNUSUALLY METAL PIECE IMBEDDED INTO THE TOP LAYER. IT APPEARED THAT THE METAL CAPS ON THE TIBIAL BASEPLATE THAT COVER THE HOLE FOR POSSIBLE AUGMENTS WERE POTENTIALLY NEVER CAPTURED UNDER THE INSERT DURING THE INITIAL PROCEDURE. PATIENT CHOSE A DIFFERENT COMPANY FOR THE REVISION WITH SURGEON DISCUSSION. EXPLANTS NOT AVAILABLE. PATIENT LEFT IN STABLE CONDITION. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 16490077 ↗

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-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-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