Optetrak Logic 02-010-03-0225Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862158000), received between Jul 14, 2021 and Oct 21, 2024 — classified as 3 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K111400); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS AND 5 MONTHS POST LEFT TOTAL KNEE ARTHROPLASTY (TKA), REVISION OF THE PROSTHESIS WAS PERFORMED DUE TO WEAR ON THE PATELLA AND TIBIAL INSERT AS WELL AS THE FEMUR ¿DEBONDED¿ FROM THE CEMENT. EVERYTHING WAS REMOVED AND REPLACED WITH A COMPETITOR PROSTHETIC. THERE WAS NO REPORTED BREAKAGE OF THE DEVICE AND NO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20495444 ↗
• InjurySep 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 63YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 5 YEARS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO FEMUR LOOSENING AND POLY WEAR. - EVERYTHING WAS REMOVED AND EXCHANGED TO A COMPETITOR¿S PRODUCT. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THEY WERE DISPOSED OF BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20301350 ↗
• InjuryJul 14, 2021Naturally Worn; Naturally Worn

  AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT, WEIGHT (B)(6) LBS., HAD KNEE PAIN 2 YEARS OUT FOLLOWING A LEFT TOTAL KNEE. THE SURGEON SCOPED THE KNEE A MONTH BACK AND NOTICED THAT THE POLY WAS WORN AND BROKEN AND PLANNED A REVISION TO TAKE THE POLY OUT AND EXCHANGING IT. PATIENT HAD THE BROKEN SIZE 2.5 CRC BY 11 MM POLY REMOVED AND REPLACED WITH A SIZE 12MM POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12170683 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013