Optetrak Logic 02-012-47-3511Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862159250), received between Nov 8, 2021 and Jul 30, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD AN INITIAL RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 9 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO A SUSPECTED INFECTION. ALL DEVICES WERE REMOVED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE HOSPITAL DISPOSED OF THEM. DEVICE IMAGES WERE PROVIDED. PROSTHESIS WEAR WAS OBSERVED ON THE EXPLANTED LINER IMAGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22669893 ↗
• InjuryMay 8, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS AND 11 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT NEEDED TO BE REVISED BECAUSE OF THE WRONG PACKED LINERS AND WEAR OF THE LINER. SOME PIECES BROKE APART FROM THE LINER AND WERE REMOVED. THE PATIENT EXPERIENCED SWELLING AND PAIN. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21984257 ↗
• InjuryAug 9, 2024Naturally Worn; Naturally Worn

  LEGAL CASE-USA. LOR FORM RECEIVED IN COMPLAINT INBOX ON 06DEC2023. NO INFORMATION PROVIDED OTHER THAN PATIENT NAME. CASE UPDATED WITH EBI DATA IDENTIFIED BASED ON PATIENT'S NAME, NO MORE INFORMATION ABOUT REVISION, SURGERY OPS REPORT PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19949446 ↗
• InjuryNov 8, 2021Naturally Worn; Naturally Worn

  AS REPORT, PATIENT REASON FOR REVISION WAS INCREASE POLY WEAR IN RIGHT KNEE. THE (B)(6) Y/O FEMALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12771652 ↗

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