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Optetrak Logic 02-012-35-3009Recalls & 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 Optetrak Logic knee replacement implant has 87 adverse event reports, all describing injuries, with no deaths. The reports mostly mention the implant wearing down, loosening, or causing pain and swelling, often needing repeat surgery. One recall, open since August 2021, covers inserts packaged in vacuum bags that lacked 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
87
Deaths reported
0
Injuries reported
87
Recalls naming it
1

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10885862001801), received between Nov 4, 2019 and Dec 15, 2025 — classified as 87 injuries.

The most frequently reported specific device problem is “Naturally Worn” (70 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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 2 reportsMar 2024: 5 reportsApr 2024: 3 reportsMay 2024: 7 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 5 reportsSep 2024: 7 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

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

Device problems

  • Naturally Worn70
  • Unstable27
  • Adverse Event Without Identified Device or Use Problem14
  • Insufficient Device Problem Information11
  • Loosening of Implant Not Related to Bone-Ingrowth8
  • Mechanical Problem4
  • Physical Resistance/Sticking2
  • Contamination1

Patient problems

  • Failure of Implant52
  • Pain38
  • Joint Laxity26
  • Osteolysis26
  • Insufficient Information23
  • Discomfort20
  • Swelling/ Edema20
  • Synovitis18

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 1 MONTH AND 5 DAYS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION (DAIR) PROCEDURE DUE TO A SUSPECTED PERIPROSTHETIC JOINT INFECTION. THE TIBIAL INSERT WAS REMOVED. THE OUTCOME IS CONSIDERED TO BE RESOLVED.

    Patient problems: Unspecified Infection

    MAUDE report 23801600 ↗
  • InjuryMay 12, 2025Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 12 YEARS POST INITIAL OPERATION. FEMUR WAS FOUND TO BE LOOSE. ALL COMPONENT WERE REMOVED AND REVISED TO A COMPETITOR'S DEVICE. THE PATIENT WAS IN STABLE CONDITION AND HAD NO KNOWN ISSUES WITH THE SURGERY. NO FURTHER INFORMATION.

    Patient problems: Inadequate Osseointegration

    MAUDE report 22003305 ↗
  • InjuryApr 23, 2025Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY 13 YEARS POST INITIAL LEFT TKA, THE 67 Y/O FEMALE PATIENT WAS HAVING PAIN. PATIENT HAD A LOOSE FEMUR THAT WAS IN FLEXION. PATIENT WAS REVISED TO FEMUR SIZE 3 CONSTRAINED, WITH POSTERIOR AND DISTAL AUGMENTS, 2° COUPLER, 16 X 1 20 STEM AND A H 32 SMALL CONE FEMORAL. A 3/15MM CONSTRAINED LINER. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS PROVIDED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THEY WERE HELD BY HOSPITAL. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT. SEE MDR#1038671-2024-00268.

    Patient problems: Pain

    MAUDE report 21896611 ↗
  • InjuryJan 22, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

    LEGAL CASE ¿ USA (B)(4) PATIENT ID: RIGHT KNEE. 9/23/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 9/16/24. ATTACHED EMAIL AND LEGAL SHORT FORM. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, (B)(4), AND PENDING IN THE (B)(6). 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. AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2010. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 12 YEARS 7 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT STATES THAT THE KNEE WAS GROSSLY UNSTABLE IN ALL PLANES THROUGH THE RANGE OF MOTION. THE SYNOVIUM WAS BLACK FROM METAL DEBRIS. THE FEMORAL

    Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

    MAUDE report 21211816 ↗
  • InjuryNov 11, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 111 MONTHS AFTER A RIGHT 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 20658050 ↗
  • InjuryOct 15, 2024Naturally Worn; Naturally Worn

    LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 127 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

    Patient problems: Insufficient Information

    MAUDE report 20457228 ↗
  • InjurySep 26, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 117 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, EFFUSION AND PAIN. 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; Synovitis

    MAUDE report 20312815 ↗
  • InjurySep 17, 2024Naturally Worn; Naturally Worn

    LEGAL CASE ¿ (B)(6). IT WAS REPORTED THAT APPROXIMATELY 130 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ENCAPSULATED POLYETHYLENE DEBRIS WITHIN THE SYNOVIUM, SEVERE OSTEOLYSIS ON FEMUR AND MODERATE ON TIBIA, SEVERE WEAR OF TIBIAL INSERT, GROSSLY LOOSE FEMORAL, PARTIALLY LOOSE TIBIAL TRAY . 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: Osteolysis; Synovitis

    MAUDE report 20241272 ↗
  • InjurySep 13, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 111 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SUFFERIING, TROUBLE WALKING/STANDING, REVISION SURGERY AND THERAPIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Ambulation or Postural Difficulties; Pain

    MAUDE report 20212297 ↗
  • InjurySep 11, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 92 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, OSTEOLYSIS, ASEPTIC LOOSENING. 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; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Pain; Synovitis

    MAUDE report 20190492 ↗
  • InjurySep 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    QIT WAS REPORTED THAT APPROXIMATELY 71 MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 20163422 ↗
  • InjurySep 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 89 MONTHS AFTER A RIGHT 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Joint Laxity; Pain; Swelling/ Edema

    MAUDE report 20161850 ↗
  • InjurySep 5, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 143 MONTHS AFTER A RIGHT 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Discomfort; Insufficient Information; Osteolysis; Pain; Swelling/ Edema; Synovitis

    MAUDE report 20149863 ↗
  • InjuryAug 22, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 92 MONTHS AFTER A RIGHT 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 20035614 ↗
  • InjuryAug 22, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 129 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PATELLA POLYETHYLENE WEAR, SIGNIFICANTLY AT THE SUPERIOR 3RD. 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: Osteolysis

    MAUDE report 20035326 ↗
  • InjuryAug 21, 2024Naturally Worn; Naturally Worn

    LEGAL CASE - USA (MASTER CASE (B)(4). CASE NO:(B)(4). RELATED CASE: (B)(4). RK REV 1 IT WAS REPORTED THAT APPROXIMATELY 11 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 20019392 ↗
  • InjuryAug 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT APPROXIMATELY 134 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 20007218 ↗
  • InjuryAug 12, 2024Naturally Worn; Naturally Worn

    LEGAL CASE - USA. PATIENT ID: (B)(6). RELATED CASE: (B)(4). THIS PATIENT IS VERIFIED BILATERAL KNEES ON PRIMARY LEFT KNEE (B)(6) 2011 AND RIGHT KNEE (B)(6) 2013 BOTH AT HOSPITAL OF SPECIAL SURGERY. SHE HAD LEFT KNEE REVISION (B)(6) 2023 WITH DR. (B)(6) (ALREADY APPROVED). SHE HAD RIGHT KNEE REVISION (B)(6) 2024 WITH DR (B)(6) (OP REPORT ATTACHED). PLEASE REVIEW THE ATTACHED REVISION OP REPORT AND CONFIRM THIS IS WITHIN THE SCOPE OF THE RECALL. PREVIOUSLY VERIFIED ON HSS MASTER LIST. CLAIM IS NOW ACCEPTED AS COMPENSABLE. PATIENT NAME: (B)(6). SURGERY 2: (B)(6), (B)(6) 2013, RIGHT KNEE PRIMARY, SERIAL #: (B)(6). NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. UNABLE TO LOCATE EBI INITIAL SURGERY. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER INFORMATION. (B)(6), 02-012-35-3009, LOGIC TIBIA PS MOD INSRT SZ 3 9MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. UDI: (B)(4). 510K: K033883.

    Patient problems: Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

    MAUDE report 19959749 ↗
  • InjuryJun 24, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 10 YEARS LATER THE PATIENT WAS REVISED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 19602181 ↗
  • InjuryMay 23, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 54 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, "CATCHING SENSATIONS", NUMBNESS, SWELLING, LIMITED RANGE OF MOTION, AND LOSS OF MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Loss of Range of Motion; Numbness; Pain; Swelling/ Edema

    MAUDE report 19387919 ↗
  • InjuryMay 23, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 58 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, "CATCHING SENSATIONS", NUMBNESS, SWELLING, LIMITED RANGE OF MOTION, AND LOSS OF MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Loss of Range of Motion; Numbness; Pain; Swelling/ Edema

    MAUDE report 19387795 ↗
  • InjuryMay 23, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 86 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, WEAKNESS, SWELLING, MECHANICAL INSTABILITY, LIMITED RANGE OF MOTION AND LOSS OF MOBILITY. 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; Insufficient Information; Loss of Range of Motion; Swelling/ Edema

    MAUDE report 19387767 ↗
  • InjuryMay 22, 2024Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT APPROXIMATELY 63 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DISSOLUTION OF POLY LINER, EXTENSIVE OSTEOLYSIS, BONE LOSS, DISCOMFORT, HYPERTROPHIC SYNOVIUM, EXTENSIVE POLY DELAMINATION AND FRACTURING, AND LOOSE FEMORAL COMPONENT. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Osteolysis; Synovitis

    MAUDE report 19373305 ↗
  • InjuryMay 15, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 3 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PERSISTENT PAIN, SWELLING, AND LOSS OF RANGE OF MOTION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Failure of Implant; Implant Pain; Loss of Range of Motion; Pain; Swelling/ Edema

    MAUDE report 19320912 ↗
  • InjuryMay 7, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2010, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022, APPROXIMATELY 11 YEARS, 9 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Patient problems: Failure of Implant; Osteolysis

    MAUDE report 19262492 ↗

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, Classified
    Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
  • Z-0906-2015 · Oct 9, 2014 · Terminated
    Optetrak 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

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices →

Sources and updates

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