Optetrak Logic 02-013-35-2509Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862004215), received between Oct 18, 2022 and Oct 18, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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.

• MalfunctionOct 18, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A 62 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 9 MONTHS POST THE INITIAL PROCEDURE DUE TO COMPLAINTS OF STIFFNESS IN THEIR KNEE. DURING THE PROCEDURE, THE TRIAL LOGIC POLY WAS REMOVED USING THE LOGIC STYLE POLY HANDLE AND ONCE REMOVED IT WAS SHOWN THAT THE POLY TRIAL HAD BROKEN ON THE UNDERSIDE. THE SURGEON USED A RONGURE TO REMOVE THE BROKEN POLY TRIAL PIECE FROM THE TIBIAL TRAY AND WOUND. THE KNEE JOINT AND SURROUNDING WOUND WAS IRRIGATED WELL. THE NEW 9MM PS POLY IMPLANT FOR THE SZ 2.5 WAS IMPLANTED INTO THE KNEE AND A FINAL ROM WAS PERFORMED. THE SURGEON WAS SATISFIED. THERE WAS A SURGICAL DELAY WHILE REMOVING THE PARTS AND PIECES FROM THE WOUND SITE WITH NO ADVERSE EVENT TO THE PATIENT. THE PATIENT LEFT THE OR STABLE. THE DEVICE IS AVAILABLE FOR RETURN. THE REVISION PROCEDURE IS REPORTED UNDER REPORT #1038671-2022-01327.

  Patient problems: Loss of Range of Motion

  MAUDE report 15629245 ↗