Optetrak Logic 02-012-35-2513Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862001788), received between Feb 9, 2023 and Jan 6, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K093360); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, INITIAL LEFT KNEE IMPLANTED WITH AN OPTETRAK INSERT MADE OF POLYETHYLENE ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021, APPROXIMATELY 6 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. PATIENT EXPERIENCED PROTHESIS WEAR, LOOSENING, OSTEOLYSIS, AMBULATION OR POSTURAL DIFFICULTIES AND PAIN. NO FURTHER INFORMATION.

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

  MAUDE report 21085882 ↗
• InjurySep 30, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4). PATIENT ID: (B)(6) + LEFT KNEE. IT IS REPORTED VIA LEGAL DOCUMENTATION THE PLAINTIFF UNDERWENT LEFT KNEE REPLACEMENT B(B)(6) 2016 AND IS CURRENTLY UNREVISED (SHORT FORM COMPLAINT ATTACHED). THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (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 A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE.

  Patient problems: Insufficient Information

  MAUDE report 20333290 ↗
• InjurySep 23, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THIS FEMALE PATIENT WAS BEING REVISED DUE TO A LOOSE FEMUR AND TIBIA. PATELLA WAS INTACT. THE TIBIAL BASEPLATE POLYETHYLENE SHOWED WEAR. SHOWED A SIGNIFICANT AMOUNT OF OSTEOLYSIS. A LARGE SOFT TISSUE RESECTION WAS DONE AND FRESH FROZEN SPECIMENS WERE SENT OFF. ASPIRATION SPECIMEN CAME BACK AS NEGATIVE WITH NO ORGANISMS SEEN. GENERALIZED INFLAMMATION WITH FIBROTIC TISSUE. THE PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS ENCOUNTERED. PATIENT WAS REVISED TO COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION.

  Patient problems: Implant Pain; Osteolysis; Pain

  MAUDE report 20278268 ↗
• InjuryJun 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 140 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, SEVERE OSTEOLYSIS , FEMORAL DEBONDING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity; Osteolysis

  MAUDE report 19478746 ↗
• InjuryMay 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 151 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION SURGERY FOR PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint effusion; Pain

  MAUDE report 19334990 ↗
• InjuryAug 30, 2023Mechanical Problem; Unstable; Naturally Worn; Insufficient Device Problem Information; Mechanical Problem; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2014. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION SURGERY (B)(6) 2023 9 YEARS POST PRIMARY PROCEDURE. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: PERIPROSTHETIC OSTEOLYSIS OF LEFT TKA. SURGEON NOTED THERE WAS EVIDENCE OF FEMORAL PROSTHESIS LOOSENING AND DEBONDING AND POLYETHYLENE WEAR. THE TIBIAL PROSTHESIS WAS WELL FIXED. AFTER THE TIBIAL CANAL WAS RE-ESTABLISHED, THERE WAS NOTED TO BE A METAPHYSEAL VOID THAT REQUIRED A CONE. THE PATELLA BUTTON WAS REMOVED AND A LARGE AMOUNT OF OSTEOLYSIS WAS CURRETTED. PROCEDURE FINDINGS: SEVERE BONE LOSS SECONDARY TO OSTEOLYSIS IN FEMUR; MILD OSTEOLYSIS IN TIBIA; SEVERE OSTEOLYSIS AND BONE LOSS IN PATELLA. 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.

  Patient problems: Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 17650997 ↗
• InjuryMar 24, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2021, THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY 1 AND ONE-HALF MONTHS AFTER THE FIRST REVISION OF THE RIGHT EXACTECH KNEE DEVICE WITH POLYETHYLENE LINER EXCHANGE AND IRRIGATION AND DEBRIDEMENT. 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.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Joint Laxity; Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 16609022 ↗
• InjuryMar 14, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, INITIAL LEFT KNEE IMPLANTED WITH AN OPTETRAK INSERT MADE OF POLYETHYLENE ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021, APPROXIMATELY 6 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. AS A RESULT OF DEFENDANTS¿ FAILURE TO PROPERLY PACKAGE THE OPTETRAK DEVICE PRIOR TO DISTRIBUTION, THE POLYETHYLENE LINER PREMATURELY DEGRADED AND THE PLAINTIFF WAS REQUIRED TO UNDERGO REVISION SURGERY DUE TO SEVERE PAIN, SWELLING, AND INSTABILITY IN THE KNEE AND LEG. THESE INJURIES WERE CAUSED BY EARLY AND PREVENTABLE WEAR OF THE POLYETHYLENE INSERT AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS AND OTHER INJURIES. 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 A

  Patient problems: Pain

  MAUDE report 16541915 ↗
• InjuryFeb 14, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT PATIENT, INITIAL TOTAL LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2012 AND WAS IMPLANTED WITH AN EXACTECH KNEE SYSTEM. IN THE ENSUING TIME, PLAINTIFF BEGAN TO SUFFER FROM SYMPTOMS ASSOCIATED WITH THE DEFECTS OF EXACTECH KNEE SYSTEM AS ALLEGED IN THIS COMPLAINT, INCLUDING PAIN AND LACK OF MOBILITY. AS A RESULT OF THESE SYMPTOMS, PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2017, APPROXIMATELY 5 YEARS POST THE INITIAL PROCEDURE. THE CLINICAL FINDINGS AND DIAGNOSES AS A RESULT OF THE REVISION SURGERY ARE CONSISTENT WITH THE DEFECTS OF THE EXACTECH KNEE SYSTEM, AS ALLEGED IN THIS COMPLAINT. PLAINTIFF EXPERIENCES, PAIN, LACK OF MOBILITY AND ENDURING LIMITATIONS ON ACTIVITIES OF DAILY LIVING, QUALITY OF LIFE, AND ABILITY TO PERFORM WORK FUNCTIONS. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Osteolysis; Synovitis

  MAUDE report 16371777 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE LEGAL DEPARTMENT THAT THIS FEMALE PATIENT'S KNEE WAS REVISED DUE TO PAIN AND LACK OF MOBILITY APPROXIMATELY 7 YEARS POST OP INITIAL TKA. AS A RESULT OF THE DEFECTS AND FAILURE OF THE EXACTECH KNEE SYSTEM, AND THE SURGICAL INTERVENTION NECESSITATED BY SUCH, THE PATIENT EXPERIENCES PAIN, LACK OF MOBILITY AND ENDURE LIMITATIONS ON ACTIVITIES OF DAILY LIVING, QUALITY OF LIFE, AND ABILITY TO PERFORM WORK FUNCTIONS.

  Patient problems: Failure of Implant

  MAUDE report 16333723 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093360. One submission often covers many models, so check the product and lot details in each record.

• Z-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ