Optetrak Logic 02-012-47-2515Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862159175), received between Mar 9, 2021 and Jun 25, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 8 YEARS, 7 MONTHS LATER THE PATIENT WAS REVISED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19611244 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY EIGHT YEARS POST TKA, THE PATIENT EXPERIENCED AN INFECTION. AT 2019 FOLLOW UP, PATIENT HAD SOME PAIN AND PT WAS PRESCRIBED. PATIENT WENT TO GET A SECOND OPINION AND FOUND THAT THEY HAD A SLOW-GROWING BACTERIAL INFECTION. IMPLANT WAS TAKEN OUT AND A NON-EXACTECH ANTIBIOTIC SPACER WAS PLACED IN BY THAT SURGEON. THE EVENT IS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Bacterial Infection

  MAUDE report 12338820 ↗
• InjuryMar 9, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YRS POSTOP, THIS (B)(6) FEMALE PATIENT CAME IN THREE WEEKS AGO TO SEE SURGEON ON X-RAY SHOWED THAT THE RIGHT FEMORAL COMPONENT HAS MOVED AND WENT INTO FLEXION WITH SIGNIFICANT WEAR TO THE INSERT. COMPONENT OF LOOSE AND INFLECTION AND SIGNIFICANT WEAR TO THE INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 11448332 ↗

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