Optetrak Logic 02-012-48-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862174291), received between Apr 7, 2021 and Jul 9, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 77 YO FEMALE PATIENT WHO HAD A LEFT SIDE KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THEY HAD POOR PROSTHETIC EVOLUTION FOLLOWING THE IMMEDIATE POSTOPERATIVE PERIOD, WITH PERSISTENT PAIN AND RECURRENT JOINT EFFUSION. THE PATIENT PRESENTED TO THE EMERGENCY DEPT WITH INCREASED PAIN, ALONG WITH AUDIBLE PROSTHETIC CLICKING DURING CERTAIN MOVEMENTS AND JOINT EFFUSION. X-RAY REVEALED ASYMMETRY IN THE MEDIAL AND LATERAL JOINT SPACES BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, SUGGESTIVE OF POLYETHYLENE FAILURE. A BONE SCAN CONFIRMED LOOSENING OF THE PROSTHETIC COMPONENTS. THE SURGERY PERFORMED REVEALED EXTENSIVE GRAYISH PERIPROSTHETIC MATERIAL SUGGESTIVE OF METALLOSIS. THE POLYETHYLENE WAS REMOVED, REVEALING ABNORMAL WEAR IN THE POSTERIOR-LATERAL REGION, WHICH HAD RELEASED POLYETHYLENE DEBRIS INTO THE PATIENT'S SOFT TISSUE. ALL PROSTHETIC COMPONENTS WERE REMOVED, AS WELL AS ALL TISSUE SUGGESTIVE OF METALLOSIS EXCISED, AND A REVISION TOTAL KNEE REPLACEMENT OF A COMPETITOR¿S DEVICES WERE IMPLANTED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STA

  Patient problems: Aseptic loosening; Joint effusion; Metal Related Pathology; Pain

  MAUDE report 22456409 ↗
• InjuryJul 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 70 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19806232 ↗
• InjuryNov 13, 2023Peeled/Delaminated; Unstable; Naturally Worn; Insufficient Device Problem Information; Peeled/Delaminated; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. THIS DEVICE HAS NOT BEEN EXPLANTED. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), 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.

  Patient problems: Insufficient Information; Joint Laxity; Pain

  MAUDE report 18119248 ↗
• InjuryNov 13, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  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) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), 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.

  Patient problems: Insufficient Information; Joint Laxity; Pain

  MAUDE report 18118760 ↗
• InjuryAug 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP INITIAL RIGHT TKA, THIS 69 Y/O FEMALE PATIENT WAS REVISED. SURGEON PERFORMED A POLY SWAP OF THE RECALLED POLY. REASON FOR THE REVISION WAS NOT REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS AVAILABLE. DEVICE NOT RETURNING - HOSPITAL KEPT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17478967 ↗
• InjuryOct 13, 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 NOTIFICATION, THAT A FEMALE PATIENT, INITIAL RIGHT KNEE ARTHROPLASTY WITH AN OPTETRAK DEVICE, INCLUDING A SIZE 2, 11 MM OPTETRAK LOGIC TIBIAL INSERTS MADE OF POLYETHYLENE, PERFORMED ON (B)(6) 2019, HAS HAD, AND CONTINUES TO HAVE PAIN AND SWELLING IN HER RIGHT KNEE. PLAINTIFF¿S TREATING PHYSICIAN HAS RECOMMENDED SHE UNDERGO A REVISION SURGERY AS HER ¿TKA [IS] WORRISOME FOR PREMATURE POLY[ETHYLENE] WEAR¿.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15595069 ↗
• InjuryApr 7, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3.5 YEARS POSTOP HER RIGHT TKA, THIS (B)(6) Y/O OVERWEIGHT FEMALE WAS SCHEDULED FOR A REVISION DUE TO THE POLY INSERT WAS WORN. SURGEON REMOVED AND REPLACED THE 11+ INSERT AND IMPLANTED A 17MM CRC INSERT IN ITS PLACE. OUTCOME IS UNKNOWN AT THIS POINT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 11629780 ↗

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