Optetrak Logic 02-012-45-6050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862004079), received between Oct 8, 2019 and Mar 4, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA MEDWATCH, PATIENT HAD KNEE REPLACEMENT DONE THREE YEARS AGO. IN 2023 PATIENT STARTED TO EXPERIENCE PAIN AND SWELLING, PATIENT HAD X-RAY DONE AND THE PHYSICIAN CONFIRMED THAT THE PATIENT WOULD NEED KNEE REPLACEMENT AGAIN DUE TO A RECALL ON THE PRODUCT. PATIENT HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Cyst(s); Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21516408 ↗
• InjuryOct 8, 2019Appropriate Device Problem Term/Code Not Available

  REVISED DUE TO INFECTION. THE PATIENT WAS STABLE LEAVING THE OPERATING ROOM. THERE WAS NO DELAY TO THE SURGERY. THE REP WAS PRESENT AT THE TIME OF THE SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 9168849 ↗