Optetrak Logic 02-012-47-4009Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Optetrak Logic (408)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Exactech Logic knee implant is a cemented, semi-constrained knee replacement with a plastic insert (liner). The 29 reports mostly describe the plastic insert wearing down years after implantation, sometimes with pieces breaking off, the insert not locking into the tibial tray, bone loss, pain and swelling, leading to revision surgery. No deaths were reported, and all 29 reports involve injuries. One recall began in August 2021 and remains open, because the inserts were packaged in bags missing an extra oxygen barrier layer.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10885862174444), received between Jul 15, 2021 and Apr 13, 2026 — classified as 29 injuries.
The most frequently reported specific device problem is “Naturally Worn” (24 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Naturally Worn24
- Adverse Event Without Identified Device or Use Problem6
- Insufficient Device Problem Information2
- Difficult to Insert1
- Fracture1
- Loss of or Failure to Bond1
- Unstable1
Patient problems
- Failure of Implant15
- Insufficient Information10
- Osteolysis9
- Pain5
- Swelling/ Edema4
- Implant Pain3
- Ambulation or Postural Difficulties2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Naturally Worn
IT WAS REPORTED THAT A PATIENT, WHO HAD AN INITIAL LEFT KNEE IMPLANTED, DATE UNKNOWN, WAS SUCCESSFULLY REVISED TO A LOGIC CC KNEE. THE PATIENT'S LINER IS SUSPECTED TO BE PART OF THE RECALL. MULTIPLE REQUEST FOR INFORMATION WERE SENT, NO INFORMATION HAS BEEN PROVIDED. THIS IS 1 OF 2 REPORTS FOR THIS INCIDENT.
Patient problems: Insufficient Information
MAUDE report 24867495 ↗InjuryAug 12, 2025Fracture; Naturally Worn; Fracture; Naturally Worn
IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED APPROXIMATELY 5 YEARS 8 MONTHS POST INITIAL OPERATION. THE REVISION WAS DUE TO POLY WEAR; DESTROYED LINER. SOME OF THE PIECES BROKE APART FROM THE LINER.
Patient problems: Insufficient Information
MAUDE report 22782689 ↗InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT UNDERWENT A REVISION IN (B)(6) 2025. THE SURGEON REPLACED THE POLY DUE TO THE RECALL.
Patient problems: Osteolysis; Pain
MAUDE report 21567509 ↗InjuryDec 2, 2024Difficult to Insert; Difficult to Insert
AS REPORTED, APPROXIMATELY 5.5 YRS POSTOP THE INITIAL L TKA THIS PATIENT WAS SCHEDULED FOR A REVISION DUE TO INCREASE WEAR. DURING SURGERY WE NOTICED THAT THE INSERT WAS MOVING WITHIN THE TIBIAL TRAY. THE POLY WAS REMOVED AND A NEW SIZE 4 / 9MM NEUTRAL WAS INSERTED AND STILL HAD THE SAME ISSUE THE POLY APPEARED NOT TO BE LOCKING INTO THE TIBIAL TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.
Patient problems: Insufficient Information
MAUDE report 20820481 ↗InjurySep 23, 2024Naturally Worn; Naturally Worn
LEGAL CASE ¿ USA (MDL NO. 3044) CASE-(B)(4) LK IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 131 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS; COST OF MEDICAL CARE, REHABILITATION, HOME HEALTH CARE, LOSS OF EARNING CAPACITY, MENTAL AND EMOTIONAL DISTRESS, PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022 OR THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.
Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Emotional Changes; Osteolysis; Pain
MAUDE report 20286561 ↗InjurySep 23, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 59 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS; COST OF MEDICAL CARE, REHABILITATION, HOME HEALTH CARE, LOSS OF EARNING CAPACITY, MENTAL AND EMOTIONAL DISTRESS, PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Emotional Changes; Osteolysis; Pain
MAUDE report 20278285 ↗InjuryJul 18, 2024Naturally Worn; Naturally Worn
AS REPORTED, THE 84 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2017. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO FEMUR LOOSENING, OSTEOLYSIS, AND POLY WEAR. 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: Osteolysis
MAUDE report 19771480 ↗InjuryJun 21, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem
AS REPORTED, APPROXIMATELY 10 YEARS POST INITIAL LEFT TKA, THE 79 Y/O MALE PATIENT HAD A POLY SWAP DUE TO INFECTION. DURING CASE, IT WAS FOUND THAT IT WAS IN FACT A RECALL POLY. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICE IS AVAILABLE FOR EVALUATION.
Patient problems: Medical device site infection
MAUDE report 19580192 ↗InjuryApr 16, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 9 YEARS AFTER INITIAL IMPLANT. THERE IS NO DEVICE INFORMATION PROVIDED. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 19122647 ↗InjuryApr 15, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT A 69 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 7 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO FEMUR LOOSENING, OSTEOLYSIS AND POLY WEAR. ALL COMPONENTS WERE REMOVED AND WERE REPLACED BY A COMPETITOR¿S REVISION KNEE. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THEY WERE DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 19110375 ↗InjuryApr 15, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT/RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 19103395 ↗InjuryMar 7, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 6 YEARS, 2 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING OF LEFT TOTAL KNEE ARTHROPLASTY. THE PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. INSPECTION OF THE PROSTHETIC KNEE COMPONENTS REVEALED SIGNIFICANT POLYETHYLENE WEAR ON THE LATERAL FACET OF THE PATELLA COMPONENT. THE TIBIAL POLYETHYLENE SHOWED PRONOUNCED POLYETHYLENE WEAR IN THE LATERAL COMPARTMENT. THE PATIENT WAS AWAKENED AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Failure of Implant; Implant Pain; Osteolysis; Swelling/ Edema
MAUDE report 18856776 ↗InjuryFeb 29, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 10 YEARS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023 ¿ POSTOPERATIVE DIAGNOSIS: FAILURE OF RIGHT TOTAL KNEE ARTHROPLASTY DUE TO FAILURE OF TIBIAL POLYETHYLENE AND PATELLAR BUTTON. REVISION OF TIBIAL AND PATELLAR COMPONENTS. PATIENT REVISED TO EXACTECH DEVICES. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Failure of Implant; Implant Pain; Synovitis
MAUDE report 18812765 ↗InjuryJan 9, 2024Naturally Worn; Naturally Worn
AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT TKA, THE 70 Y/O MALE PATIENT WAS REVISED DUE TO POLY WEAR AND DELAMINATION. THE PATIENT WAS REVISED TO A SZ4, 9MM TIBIAL INSERT. THE PATELLA WAS REMOVED. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED AT HOSPITAL.
Patient problems: Failure of Implant
MAUDE report 18480489 ↗InjuryDec 11, 2023Naturally Worn; Naturally Worn
AS REPORTED, APPROXIMATELY 8 YEARS POST OP INITIAL LEFT TKA, THIS MALE PATIENT WAS REVISED DUE TO POLY WEAR. EVERYTHING WAS REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISPOSED AT HOSPITAL. UNABLE TO OBTAIN PHOTOS/X-RAYS.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 18300091 ↗InjuryNov 17, 2023Unstable; Naturally Worn; Unstable; Naturally Worn
IT WAS REPORTED THAT HTIS 55 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED. THE PATIENT RETURNED TO SURGEONS OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. THE PATIENT UNDERWENT A POLY INSERT SWAP AND PATELLA IMPLANT SWAP. THE SURGEON REMOVED ALL VISIBLE DEBRIS AND IRRIGATED AND DEBRIDED THE WOUND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - THE IMPLANT(S) WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.
Patient problems: Failure of Implant; Joint Laxity; Pain; Swelling/ Edema
MAUDE report 18159184 ↗InjurySep 25, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD BILATERAL TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND THEN APPROXIMATELY 2 YEARS, 3 MONTHS LATER EXPERIENCED A LEFT KNEE REVISION SURGERY TO REPLACE THE TIBIAL INSERT. OPERATION REPORT OF (B)(6) 2023 -CLEAR JOINT FLUID WAS TAKEN FOR MICROBIOLOGICAL ANALYSIS. A SUBTOTAL SYNOVECTOMY WAS PERFORMED OF THE HYPERTROPHIED SYNOVIAL TISSUE AND SPECIMENS SENT FOR HISTOPATHOLOGICAL ANALYSIS. THE TIBIOFEMORAL POLYETHYLENE WAS REMOVED AND FOLLOWING EXTENSIVE LAVAGE OF THE JOINT A NEW 9 MM SIZE 4 OPTETRAK CR INSERT WAS APPLIED. 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 OTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17807042 ↗InjurySep 8, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem
AS REPORTED, APPROXIMATELY NINE YEARS POST INITIAL TKA, THE MALE PATIENT WAS REVISED DUE TO BONE LOSS. THE CONES FOR BIOMET WERE NOT BIG ENOUGH TO FIX THE DEFECT SO SURGEON BAILED TO COMPETITOR'S SLEEVES. THE EXPLANTS ARE NOT AVAILABLE. NO FURTHER INFORMATION AVAILABLE. AS OF NOTE PER SURGEON; "IT WAS ONE OF THE WORST BONE LOSS CASES HE HAS SEEN.".
Patient problems: Osteolysis
MAUDE report 17711179 ↗InjuryAug 29, 2023Naturally Worn; Naturally Worn
AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL RIGHT TKA, THIS 79 Y/O MALE PATIENT WAS REVISED DUE TO POLY WEAR. FEMUR AND LINER WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - DISPOSED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 17642169 ↗InjuryAug 17, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information
AS REPORTED VIA LEGAL DOCUMENTATION, BEFORE (B)(6) 2013, THE PATIENT BEGAN MEDICAL TREATMENT FOR LEFT KNEE ARTHRITIS. ON OR ABOUT (B)(6) 2013 THE PATIENT HAD A LEFT KNEE REPLACEMENT. THE PATIENT WILL NEED A REVISION OF THE REPLACEMENT DUE TO THE POLYETHYLENE WEAR, TISSUE DAMAGE, OSTEOLYSIS, PAIN, AND SWELLING. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Insufficient Information; Osteolysis; Swelling/ Edema
MAUDE report 17562903 ↗InjuryJun 19, 2023Naturally Worn; Naturally Worn
AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2021. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR AND THE LINER WAS EXCHANGED. 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
MAUDE report 17159853 ↗InjuryMar 7, 2023Naturally Worn; Naturally Worn
AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT SIDE TKA, THE 59 Y/O FEMALE PATIENT PRESENTED BACK TO SURGEON OFFICE WITH COMPLAINTS OF DISSATISFACTION, PAIN, AND SWELLING OF THE RIGHT PRIMARY KNEE. AN EXAMINATION AND IMAGING WERE PERFORMED SHOWING POLY WEAR AND OSTEOLYSIS. THE POLY TURNED OUT TO BE AN IMPLANT HIGHLY LIKELY INVOLVED IN THE RECALL. THE PATIENT WAS SCHEDULED FOR A COMPLETE REVISION OF THE RIGHT TOTAL KNEE ON (B)(6) 2020. ALL OF THE EXACTECH IMPLANTS WERE REMOVED AND A TOTAL REVISION USING COMPETITOR'S KNEE WAS RE-IMPLANTED. THE PATIENT IS LAST KNOWN TO BE STABLE. PHOTOS AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO DEVICES DISCARDED. REVISION HAPPENED IN THE PAST.
Patient problems: Failure of Implant; Osteolysis; Pain; Swelling/ Edema
MAUDE report 16495675 ↗InjuryNov 2, 2022Naturally Worn; Naturally Worn
AS REPORTED VIA LEGAL, APPROXIMATELY 2 YEARS POST OP THE INITIAL RIGHT TKA IMPLANT, THIS MALE PATIENT WAS REVISED DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. FOLLOWING THE REVISION SURGERY, THE PATIENT "EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS RIGHT KNEE WHICH LIMITS HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE." NO ADDITIONAL INFORMATION.
Patient problems: Failure of Implant
MAUDE report 15713549 ↗InjuryOct 11, 2022Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn
IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A MALE PATIENT, INITIALLY IMPLANTED WITH AN OPTETRAK SYSTEM ON HIS LEFT KNEE ON (B)(6) 2013, UNDERWENT REVISION PROCEDURE ON (B)(6) 2020, APPROXIMATELY 7 YEARS 2 MONTHS POST THE INITIAL PROCEDURE, FOR REASONS UNKNOWN. THE SURGEON FOUND THAT THE OPTETRAK POLYETHYLENE HAD SEVERELY WORN AND CAUSED OSTEOLYSIS OF THE TIBIAL AND FEMORAL BONE, AS WELL AS LOOSENING OF THE REMAINDER OF THE DEVICE. THE SURGEON REMOVED THE FAILED LEFT SIDE OPTETRAK IMPLANT AND REPLACED IT WITH ANOTHER IMPLANT. NO FURTHER INFORMATION KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15581378 ↗InjuryOct 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2018 . THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO THE RECALL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.
Patient problems: Failure of Implant
MAUDE report 15526195 ↗
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, ClassifiedExactech 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
Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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