Optetrak Logic 02-012-48-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862174406), received between Sep 7, 2022 and Dec 7, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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.

• InjuryDec 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT 17 APR 2022 THE PREVIOUS LINER WAS DISLODGED FROM THE TIBIAL COMPONENT. UPON INSPECTION THERE WAS SEVERE DELAMINATION WEAR ON THE SURFACE OF THE POLYETHYLENE. BOTH TIBIAL AND FEMORAL COMPONENTS HAD AREA OF SEVERE OSTEOLYSIS LEADING TO DEBONDING AT THE BONE CEMENT JOINT. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis; Scar Tissue; Swelling/ Edema

  MAUDE report 18284492 ↗
• InjuryJun 1, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTS THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, THE PATIENT HAS PAIN, STIFFNESS, AND WEAKNESS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE ARE NO RADIOGRAPHS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Implant Pain; Pain; Unspecified Musculoskeletal problem

  MAUDE report 17039805 ↗
• InjuryMar 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT PRESENTED BACK TO THE SURGEON WITH COMPLAINTS OF PAIN, SWELLING, AND DISSATISFACTION WITH THEIR RIGHT TKA. AFTER EXAMINATION, THE PATIENT WAS SCHEDULED FOR INITIAL REVISION SURGERY ON (B)(6) 2022, WHERE ALL OF THE EXACTECH IMPLANTS WERE REMOVED FROM THE PATIENT. THE POLY SHOWED WEAR AND IS A PART OF THE RECALL. AN INFECTION PROPHYLACTIC ANTIBIOTIC TKA WAS PLACED ON (B)(6) 2022. THE PATIENT RETURNED ON (B)(6) 2022 FOR THE REMOVAL OF THE ANTIBIOTIC PROPHYLACTIC TKA AND WAS RE-IMPLANTED WITH A COMPETITORS REVISION TOTAL KNEE PROSTHESIS. THERE WAS NO REPORTED BREAKAGE OF DEVICES AND A 45 MINUTE SURGICAL DELAY. NO ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 16492620 ↗
• InjurySep 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. THE PATIENT HAD A POLY SWAP AND WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 15369749 ↗

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