Optetrak Logic 02-012-47-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862159243), received between Apr 12, 2021 and Jul 1, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  APPROXIMATELY 5 YEARS 3 MONTHS AFTER A TOTAL LEFT KNEE REPLACEMENT, THE PATIENT WAS REVISED DUE TO OSTEOLYSIS/LOOSENING OF THE FEMUR AS A RESULT OF PATELLA AND TIBIAL INSERT WEAR. ALL DEVICES WERE REPLACED, THE REPORTED EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE REPORTED EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Osteolysis

  MAUDE report 19650148 ↗
• InjuryJun 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE APPROXIMATELY 8 YEARS AND 1 MONTH AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT-POSTOPERATIVE DIAGNOSIS: FEMORAL LOOSENING AND EXTENSIVE POLY WEAR OSTEOLYSIS. THE PATIENT WAS REVISED TO COMPETITOR'S DEVICES. PATIENT DEVELOPED PERSISTENT LEFT KNEE PAIN AND SWELLING, EVIDENCE OF OSTEOLYSIS AND POLY WEAR SYNOVITIS. THERE WAS MODERATE CLEAR EFFUSION AND EXTENSIVE POLY WEAR SYNOVITIS. EXTENSIVE PITTING AND WEAR OVER PORTIONS OF POLY, CONSISTENT AS THE SOURCE OF THE OSTEOLYSIS AND WEAR. THE FEMUR HAS POSTERIOR OSTEOLYSIS WITH LARGE AREAS OF LOOSENING. THE PATELLAR COMPONENT WAS MAINTAINED. THE PATIENT WAS AWOKEN AND TRANSFERRED TO PACU IN STABLE CONDITION. NO COMPLICATIONS. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19578116 ↗
• InjuryDec 15, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2015. THE PATIENT PRESENTED BACK TO THE SURGEON'S OFFICE WITH COMPLAINTS OF THEIR TOTAL KNEE. THE POLYETHYLENE INSERT IS A RECALLED LINER SHOWING WEAR ON IMAGING. THE PATIENT WAS SCHEDULED FOR A KNEE REVISION AND POSSIBLE POLY EXCHANGE ON (B)(6) 2023. THE PATIENT UNDERWENT A TIBIAL POLY IMPLANT SWAP. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18334964 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY ONE YEAR POST PATIENT'S FIRST TKA REVISION, THE 60 Y/O MALE PATIENT HAD A SECOND REVISION FOR AN UNKNOWN REASON. ALL IMPLANTS WERE REMOVED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS OR X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED BY THE HOSPITAL.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information

  MAUDE report 18234543 ↗
• InjuryNov 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON 22 JUN 2020, APPROXIMATELY 10 YEARS 4 MONTHS POST PRIMARY PROCEDURE. 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 COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. 2022 CA (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18086764 ↗
• InjuryMar 1, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A PATIENT, INITIAL LEFT KNEE REPLACEMENT, IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING AN INSERT MADE OF POLYETHYLENE, ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 4 YEARS I MONTH POST THE INITIAL PROCEDURE. AS A DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE AS DESCRIBED HEREIN, THE PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. AS A FURTHER DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE, THE PLAINTIFF HAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; LOSS OF CONSORTIUM AND PAIN AND SUFFERING. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

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

  MAUDE report 16464238 ↗
• InjuryNov 14, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 64 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 1 MONTH POST THE INITIAL PROCEDURE DUE TO POLY WEAR. THE PATIENT LAST KNOWN TO BE IN STABLE CONDITION. NO OTHER PATIENT/MEDICAL INFORMATION REPORTED. THE PRODUCT IS NOT RETURNING AS IT WAS DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15790147 ↗
• InjuryApr 12, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POSTOP THE INITIAL L TKA, THE SURGEON CONDUCTED A REVISION KNEE SURGERY THAT CONSISTED OF ONLY A POLYETHYLENE SWAP THAT WAS PLACED IN ON (B)(6) 2017 FOR THIS MALE PATIENT. THE PATIENT WAS COMPLAINING OF INSTABILITY AND DISCOMFORT WHEN WALKING UP AND DOWN STAIRS. TO ADDRESS THESE CONCERNS SURGEON, REPLACED THE SIZE 3.5 (9MM) CR TIBIAL INSERT WITH A SIZE 3.5 (11MM) CRC TIBIAL INSERT. UPON REMOVAL OF THE OLD INSERT, IT WAS NOTED THAT THERE WAS WEAR ON THE POSTERIOR-MEDIAL ASPECT OF THE INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO PATIENT REQUESTED THAT THE INSERT WAS RETURNED TO HIM POST-OP.

  Patient problems: Failure of Implant

  MAUDE report 11653352 ↗

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