Optetrak Logic 02-012-35-5013Recalls & 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.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10885862001948), received between Nov 9, 2020 and Jan 13, 2025 — classified as 23 injuries.
The most frequently reported specific device problem is “Naturally Worn” (18 reports).
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls cover devices cleared under the same FDA submission (K033883); 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 Worn18
- Unstable6
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information3
- Loosening of Implant Not Related to Bone-Ingrowth3
- Detachment of Device or Device Component1
- Mechanical Problem1
Patient problems
- Failure of Implant10
- Osteolysis9
- Pain9
- Implant Pain7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Swelling/ Edema6
- Synovitis6
- Joint Laxity5
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AFTER IMPLANTATION OF A LEFT KNEE, THE INSERT HAD DISASSOCIATED FROM THE TIBIAL TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Insufficient Information
MAUDE report 21145723 ↗InjuryJan 10, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 94 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, JOINT EFFUSION, PAIN, SCAR TISSUE, AND SYNOVITIS. INITIAL SURGERY AND 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: Joint effusion; Osteolysis; Pain; Scar Tissue; Synovitis
MAUDE report 21126686 ↗InjuryJan 8, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 87 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISTRESS, OSTEOLYSIS, IMPLANT PAIN, AND JOINT EFFUSION. 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: Ambulation or Postural Difficulties; Balance Problems; Distress; Implant Pain; Joint effusion; Osteolysis
MAUDE report 21104393 ↗InjuryOct 30, 2024Unstable; Naturally Worn; Unstable; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. UPON THE REVISION OF THE OPTETRAK LOGIC DEVICE, PATIENT'S SURGEON OBSERVED SIGNS OF DEFECTIVE AND LOOSE FEMORAL COMPONENTS. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Swelling/ Edema
MAUDE report 20567164 ↗InjuryOct 17, 2024Unstable; Naturally Worn; Unstable; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 122 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY; BONY DEFECTS ON THE FEMORAL AND TIBIAL SIDE; LENGTHY AND PAINFUL RECOVERY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Implant Pain; Joint Laxity; Swelling/ Edema
MAUDE report 20469856 ↗InjurySep 16, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 110 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS AND LIMITED ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES. 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; Discomfort; Pain
MAUDE report 20230478 ↗InjurySep 9, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 108 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information; Osteolysis; Synovitis
MAUDE report 20169724 ↗InjuryAug 28, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 65 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS, OSTEOLYSIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Loss of Range of Motion; Osteolysis; Swelling/ Edema; Synovitis
MAUDE report 20089271 ↗InjuryApr 4, 2024Unstable; Naturally Worn; Unstable; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 5 YEARS AND 3 MONTHS 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain
MAUDE report 19040391 ↗InjuryMar 21, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 7 YEARS AND 6 MONTHS 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Osteolysis; Pain; Synovitis
MAUDE report 18948263 ↗InjuryNov 29, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information
AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 3 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2018. 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. REVISION OP REPORT ON (B)(6) 2018 DIAGNOSIS: ACUTE HEMATOGENOUS INFECTION, LEFT KNEE THERE WAS GROSS PURULENCE RELEASE 200 ML IN THE KNEE. SYNOVIAL TISSUE WAS BOGGY, BUT WITH MINIMAL GRANULATION AND NO ADHERENCE TO THE UNDERLYING TISSUE. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY IN STABLE CONDITION. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) 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 COMPLICATION
Patient problems: Fever; Implant Pain; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Infection
MAUDE report 18230440 ↗InjuryOct 31, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem
AS REPORTED, APPROXIMATELY SEVEN YEARS POST LEFT REVISION TKA, THE 72 Y/O MALE PATIENT BEGIN TO EXPERIENCE SPILL AND PAIN. THEN, THREE MONTHS LATER LYSIS ON FEMORAL AND TIBIAL WAS OBSERVED. THE PATIENT WAS REVISED TO COMPETITOR'S DEVICE ON (B)(6) 2023. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Joint effusion; Osteolysis; Pain
MAUDE report 18040187 ↗InjuryOct 18, 2023Naturally Worn; Naturally Worn
AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 8 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. 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. REVISION OP REPORT ON (B)(6) 2023: DIAGNOSIS: POLY WEAR AND DEBRIS THE PATELLA WAS EVALUATED AND SHOWED MODERATE WEAR, ESPECIALLY LATERALLY. THE PATELLA WAS REVISED. MOVED ON TO THE TIBIA. REMOVED THE OLD POLY. THERE WAS SIGNIFICANT POSTERIOR WEAR OF THE POLY NOT COMPLETELY THROUGH, BUT CERTAINLY DISEASED POSTERIORLY.
Patient problems: Failure of Implant; Pain; Swelling/ Edema; Synovitis
MAUDE report 17959962 ↗InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, THE PATIENT HAD AN INFECTION ON (B)(6) 2015. THE PATIENT PRESENTED ON (B)(6) 2018 AND HAD SINUS SURGERY AND DEVELOPED INCREASED SWELLING AND PAIN IN THE LEFT TOTAL KNEE. UNABLE TO BEAR WEIGHT ON THE LEG AND PRESENTED TO THE OFFICE. ASPIRATION WAS POSITIVE FOR STREPTOCOCCUS. UNDERWENT I AND D WITH POLY EXCHANGE AND SIX WEEKS OF IV ANTIBIOTICS. THE PATIENT WAS REVISED (B)(6) 2018. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY NOT RELATED TO DEVICE, DEFINITELY NOT RELATED TO PROCEDURE (OBTAINED FROM BRIEF SUMMARY OF ZELTA). OUTCOME: RESOLVED ON (B)(6) 2018.
Patient problems: Bacterial Infection; Implant Pain; Inflammation; Medical device site infection
MAUDE report 17709675 ↗InjuryJul 11, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information
AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6)2014. THE PATIENT WAS REVISED ON (B)(6)2022; REASON NOT REPORTED. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 17303181 ↗InjuryJul 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT SURGERY ON (B)(6) 2011. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2021, APPROXIMATELY 10 YEARS AFTER THEIR PRIMARY PROCEDURE. (B)(6) 2021 OP REPORT STATES THAT THE PATIENT PRESENTED WITH A PAINFUL AND UNSTABLE LEFT KNEE REPLACEMENT. THE PATIENT NOTED TO HAVE ASEPTIC LOOSENING. X-RAY DEMONSTRATED OSTEOLYSIS AND MIGRATION OF THE FEMORAL COMPONENT. MRI CONFIRMED THIS AND NOTED OSTEOLYSIS AND LOOSENING OF THE PATELLA. THERE WAS A VERY LARGE CALCIFIC REGION LATERAL TO THE PATELLA THAT WAS VISUALIZED ON THE MERCHANT VIEW THAT WAS EXCISED. THE LINER WAS REMOVED, AND THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND WAS REMOVED AS WELL. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH OSTEOLYSIS. TIBIAL COMPONENT WAS ALSO REMOVED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. 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.
Patient problems: Joint Laxity
MAUDE report 17278514 ↗InjuryMay 3, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2012. HE HAD LEFT KNEE REVISION (B)(6) 2022, APPROXIMATELY 10 YEARS AFTER THEIR INITIAL PROCEDURE. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO ASEPTIC LOOSENING AND OSTEOLYSIS. SURGEON FOUND EXUBERANT HYPERTROPHIC FOREIGN BODY REACTION OF THE SYNOVIUM. THE FEMORAL COMPONENT WAS GROSSLY LOOSE. THERE WERE WELL CONTAINED OSTEOLYTIC LESIONS IN THE DISTAL FEMUR. THE LESIONS OF THE PROXIMAL TIBIA WERE WELL CONTAINED IN THE MEDIAL TIBIAL PLATEAU. THERE WAS GROSS OSTEOLYSIS ON THE TIBIAL TRAY. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Implant Pain; Osteolysis
MAUDE report 16862666 ↗InjurySep 29, 2022Unstable; Naturally 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 A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021, APPROXIMATELY 3 YEARS 10 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR REASONS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Discomfort; Joint Laxity; No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain; Swelling/ Edema
MAUDE report 15503469 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 56 YO MALE PATIENT, INITIALLY IMPLANTED ON THE RIGHT KNEE ON (B)(6) 2015, WAS SEEN IN THE OFFICE FOR KNEE PAIN AND INSTABILITY. THEY WERE REVISED TO A CC KNEE APPROXIMATELY 7 YEARS 5 MONTHS POST THE INITIAL IMPLANT PROCEDURE. THE KNEE WAS REVISED TO A LARGE H32 FEMORAL CONE AND A TIBIAL CON ML 39. THE FEMUR IS REVISED TO CONSTRAINED CONDYLAR SIZE 4 WITH A SIZE 4 TIBIA. THE FEMUR HAD A 20 X 120 STEM AND TIBIA HAD A 16 X 80 STEM WITH A SIZE 4/19 MM CONSTRAINED INSERT LINER. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE AVAILABLE FOR RETURN.
Patient problems: Pain
MAUDE report 15348116 ↗InjuryAug 31, 2022Naturally Worn; Naturally Worn
AS REPORTED, APPROXIMATELY 13 YEARS POST OP THE INITIAL TKA, THIS MALE PATIENT WAS REVISED DUE TO POLY WEAR. PATIENT WAS REVISED TO A LOGIC PSC SIZE 5 15MM INSERT.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 15326380 ↗InjuryFeb 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED, APPROXIMATELY 3.86 YEARS SINCE INITIAL IMPLANT, THIS MALE PATIENT (B)(6) UNDERWENT A LEFT SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL # (B)(4). ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.
Patient problems: Failure of Implant
MAUDE report 13453326 ↗InjuryFeb 1, 2022Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED, APPROXIMATELY 9 YEARS AND 10 MONTHS POST LEFT SIDE TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: Cyst(s); Failure of Implant; Joint Laxity; Osteolysis; Pain; Scar Tissue
MAUDE report 13418991 ↗InjuryNov 9, 2020Unstable; Unstable
IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2013, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2012. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 10808419 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.
- Z-0584-2024 · Nov 21, 2023 · Open, ClassifiedExactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
- Z-0906-2015 · Oct 9, 2014 · TerminatedOptetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
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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