Optetrak Logic 02-010-04-0235Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862158260), received between Jul 1, 2024 and Dec 11, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT TKA, THE 68 Y/O FEMALE PATIENT WAS REVISED DUE TO OSTEOLYSIS AND POLYETHYLENE WEAR. THE PATIENT EXPERIENCED SYNOVITIS AND IMPLANT PAIN. ALL THE IMPLANTS WERE REMOVED AND REVISED IN TO COMPETITOR¿S PRODUCTS. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS ATTACHED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THEY WERE DISPOSED AT THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Osteolysis; Synovitis

  MAUDE report 20907991 ↗
• InjuryNov 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS AND 4 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO POLY AND PATELLA WEAR, AND FEMORAL LOOSENING. THE TIBIAL INSERT WAS REVISED TO SIZE 3.5, 11MM. THE FEMORAL COMPONENT WAS REVISED TO SIZE 3.5. 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: Insufficient Information

  MAUDE report 20701017 ↗
• InjuryAug 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL LEFT TKA, THIS 73 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR AND FEMUR LOOSENING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISPOSED.

  Patient problems: Insufficient Information

  MAUDE report 20072721 ↗
• InjuryJul 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED, A 64 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6), 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 1 YEAR 7 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO FEMUR LOOSING FROM POLY AND PATELLA WEAR. EVERYTHING WAS REMOVED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAY DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS PROVIDED. NO DEVICES RETURNING FOR ANALYSIS. THEY WERE DISCARDED AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS WAS THE 2ND REVISION FOR THIS PATIENT. 1ST REVISION REPORTED UNDER MDR# 1038671-2022-01115.

  Patient problems: Insufficient Information

  MAUDE report 19833478 ↗
• InjuryJul 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 5 YEARS 3 MONTHS AFTER A TOTAL LEFT KNEE REPLACEMENT, THE PATIENT WAS REVISED DUE TO OSTEOLYSIS/LOOSENING OF THE FEMUR AS A RESULT OF PATELLA AND TIBIAL INSERT WEAR. ALL DEVICES WERE REPLACED, THE REPORTED EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE REPORTED EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED AT THE HOSPITAL. .

  Patient problems: Osteolysis

  MAUDE report 19647197 ↗