Optetrak Logic 02-012-45-3525Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862003980), received between Dec 11, 2024 and Feb 25, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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.

• InjuryFeb 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YEARS AND 1 MONTH POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THIS CASE WAS SCHEDULED AS JUST A POLY EXCHANGE DUE TO THE RECALL. ONCE THE SURGEON DISSECTED DOWN HE REALIZED THE FEMUR WAS FALLING OFF AND THERE WAS LOTS OF OSTEOLYSIS, SO HE REVISED TO COMPETITOR'S DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 21465422 ↗
• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 148 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PROGRESSIVE AND DEBILITATING KNEE PAIN SECONDARY TO ASEPTIC LOOSENING, POLYETHYLENE WAR AND OSTEOLYSIS. REVISION OPERATIVE REPORTS WERE PROVIDED. INTRAOPERATIVELY THE SURGEON OBSERVED ASEPTIC LOOSENING OF THE FEMUR AND TIBIAL TRAY, POLYETHYLENE WEAR OF THE INSERT, SIGNIFICANT SURFACE DAMAGE, DELAMINATION AND PITTING ON THE PATELLA, WHICH WAS FRACTURED AND LOOSE. IT WAS NOTED THE SURGICAL PROCEDURE WAS SIGNIFICANTLY DIFFICULT DUE TO PATIENT'S HEIGHT AND WEIGHT WHICH REQUIRED ADDITIONAL SURGICAL DISSECTION. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. IMPACTOR AND THE TIBIAL COMPONENT CAREFULLY REMOVED, WHICH WAS ALSO 02-012-35-3511 - LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM. SERIAL: (B)(6). 510K: K093360 UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: YES.

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 20902659 ↗