Optetrak Logic 02-012-49-3513Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862159335), received between Sep 16, 2022 and Sep 9, 2024 — 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.

• InjurySep 9, 2024Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  IT WAS REPORTED THAT THIS 64 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED. THE PATIENT HAD AN ORIGINAL EXACTECH LEFT TOTAL KNEE REPLACEMENT. THE PATIENT RETURNED TO SURGEONS OFFICE COMPLAINING OF PAIN, SWELLING, AND DISSATISFACTION WITH THEIR LEFT PRIMARY KNEE. THE POLY AND A RECALLED IMPLANT WERE IN QUESTION. THE POLY IMPLANT WAS BROKEN POSTERIORLY IN A COUPLE OF PIECES THAT WERE REMOVED FROM THE WOUND/JOINT. THE PATIENT UNDERWENT A TIBIAL POLY IMPLANT SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: IMPLANTS ARE SENT TO THE LAB AND LEGAL. NOT GIVEN TO THE REPRESENTATIVE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20177426 ↗
• InjuryJul 18, 2024Naturally Worn; Naturally Worn

  "LEGAL CASE ¿ USA (MDL NO. 3044) PATIENT ID: (B)(6) + LEFT KNEE (B)(4) RK REV IS ASSOCIATED WITH THIS CASE" "THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE" "THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022 02-012-49-3513 - LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM SERIAL:(B)(6). 510K: K111400 UDI: (B)(4). PRODUCT CODE: JWH X-RAY: NO OPERATIVE NOTES: NO. CONCOMITANT DEVICES: (5241951) 02-012-45-3545 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 4.5T, (5343760) 200-02-32 - THREE PEG PATELLA 32MM, (5361734) 02-01

  Patient problems: Insufficient Information

  MAUDE report 19770619 ↗
• InjuryFeb 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED A 73 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 4 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. UPON EXAMINATION, THE PATIENT WAS SCHEDULED FOR A REVISION TKA, POSSIBLE POLY SWAP. DURING THE PROCEDURE, THE POLY AND PATELLA IMPLANTS WERE SWAPPED. REVISED TO A TRULIANT CRC TIBIAL INSERT SZ 3.5, 15MM SN: (B)(6) AND AN OPTETRAK 3 PEG PATELLA 32MM SN: (B)(6). THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS FOR ANALYSIS ANTICIPATED. THE DEVICES WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Implant Pain; Inflammation; Joint Laxity; Joint effusion; Muscle/Tendon Damage; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18655498 ↗
• InjurySep 16, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL TOLLING AGREEMENT THAT A MALE PATIENT WHO WAS INITIALLY IMPLANTED ON THE LEFT KNEE ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020, APPROXIMATELY 2 YEARS 11 MONTHS POST THE INITIAL PROCEDURE FOR REASONS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 15439924 ↗

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