Optetrak Logic 02-012-51-3009Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10885862230409), received between Jun 8, 2023 and Sep 23, 2024 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (17 reports).

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

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 120 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SIGNIFICANT PAIN AND DISCOMFORT, 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, AND PAIN AND SUFFERING; LIKELY REVISION SURGERY. 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; Emotional Changes; Osteolysis; Pain

  MAUDE report 20279391 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP INITIAL RIGHT TKA, THIS 60 Y/O FEMALE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING AND POLY WEAR. FEMUR AND LINER WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISPOSED AT HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 20072744 ↗
• InjuryAug 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 67/ Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED 2 YEARS 2 MONTHS POST OP. EVERYTHING WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT. EVERYTHING WAS REMOVED AND REPLACED WITH THE COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISCARDED AT THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 19943231 ↗
• InjuryJul 24, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, OSTEOARTHRITIS, ARTHROFIBROSIS, DISCOMFORT, INABILITY TO WALK UP AND DOWN STAIRS BECAUSE OF STIFFNESS; ATRAUMATIC MENISCUS TEAR; SYNOVECTOMY, ARTHROSCOPIC PARTIAL MENISCECTOMY. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Discomfort; Loss of Range of Motion; Pain

  MAUDE report 19822286 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 42 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLAR COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IMAGES AND X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cellulitis; Cyst(s); Implant Pain; Insufficient Information; Medical device site infection; Synovitis

  MAUDE report 19651792 ↗
• InjuryJun 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 49 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEARPAIN, SWELLING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 19619118 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE 78 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO POLY DELAMINATION AND PITTING. EVERYTHING WAS REMOVED. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. 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. PRODUCT NOT RETURNING: DISPOSED AT HOSPITAL. UNABLE TO OBTAIN X-RAYS.

  Patient problems: Failure of Implant

  MAUDE report 19512144 ↗
• InjuryMay 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 36 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SEVERE PAIN, SIGNIFICANT SCARRING, SWELLING, EFFUSION, INFLAMMATION, KNEE POPPING/CLUNKING, KNEE GIVING AWAY, DIFFICULTY WALKING, ANTALGIC GAIT, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Implant Pain; Inflammation; Joint effusion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19237968 ↗
• InjuryMay 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 31 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SEVERE PAIN, SIGNIFICANT SCARRING, SWELLING, EFFUSION, INFLAMMATION, KNEE POPPING/CLUNKING, KNEE GIVING AWAY, DIFFICULTY WALKING, ANTALGIC GAIT, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Discomfort; Failure of Implant; Implant Pain; Inflammation; Joint effusion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19237790 ↗
• InjuryApr 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 3 YEARS AND 1 MONTH AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 19124577 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT KNEE TOTAL ARTHROPLASTY ON (B)(6) 2019 AND THEN APPROXIMATELY 1 YEAR 5 MONTHS LATER ON (B)(6) 2021 THE PATIENT HAD A SURGICAL REVISION. REVISION OPERATIVE REPORT OF (B)(6) 2021 - POSTOPERATIVE DIAGNOSIS- FAILED KNEE DUE TO ARTHROFIBROSIS. PATIENT WAS REVISED TO COMPETITOR DEVICES. PATIENT PRESENTED WITH A PAINFUL KNEE. NEGATIVE FOR INFECTION. FULL REVISION TO ALLOW REBOUND SINGH OF THE LIGAMENTS. EXTENSIVELY DEBRIDED SCAR AND SYNOVIAL TISSUE FROM THE MEDIAL AND LATERAL GUTTERS. THE SUPERFICIAL AND DEEP ADHESIONS AROUND THE EXTENSOR MECHANISM TO ALLOW FLEXION OF THE KNEE WERE RELEASED. TIBIAL AND FEMORAL COMPONENTS WERE WELL FIXED, THEY WERE REMOVED. PATELLAR COMPONENT WAS WELL FIXED AND LEFT IN PLACE. THE PATIENT TOLERATED THE PROCEDURE WELL. 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: Adhesion(s); Arthrofibrosis; Pain; Scar Tissue

  MAUDE report 19028650 ↗
• MalfunctionMar 19, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Discomfort; Failure of Implant; Pain

  MAUDE report 18937343 ↗
• InjuryMar 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022, APPROXIMATELY 7 YEARS 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: Discomfort; Emotional Changes; Failure of Implant; Pain; Synovitis

  MAUDE report 18925687 ↗
• InjuryMar 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, INITIAL KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 7 YEARS POST THE INITIAL PROCEDURE. THE SURGEON REVISED THE PATIENT DUE TO PAIN AND SYNOVITIS. THE SURGEON NOTED WEAR. THERE WERE NO ISSUES WITH THE SURGERY. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. X-RAYS AND A DEVICE IMAGE WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Inflammation; Pain; Synovitis

  MAUDE report 18882655 ↗
• InjuryJan 9, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST INITIAL RIGHT TKA, THE 76 Y/O FEMALE PATIENT WAS REVISED DUE TO POLYETHYLENE WEAR. THE PATIENT WAS REVISED TO A SZ 3 11MM TIBIAL INSERT. THERE WAS NO BREAKAGE OF 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 DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICE WAS DISPOSED AT HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18480437 ↗
• InjuryOct 10, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE ON (B)(6) 2017. APPROXIMATELY 1 YEAR AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2019. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES, INCLUDING BUT NOT LIMITED TO, SEVERE PAIN, SWELLING, INSTABILITY, FALLS, WEAKNESS, AND LIMITED MOBILITY. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17903833 ↗
• InjurySep 28, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTAL THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. THE DEVICE HAS NOT BEEN EXPLANTED. THE PATIENT HAS EXPERIENCED DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE. THE PATIENT HAS SUFFERED DEBILITATING INJURES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE. 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 MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. 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 problems: Balance Problems; Discomfort; Emotional Changes; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 17832635 ↗
• InjuryJun 8, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 AND THEN APPROXIMATELY 4 YEARS, 8 MONTHS LATER WAS REVISED ON (B)(6) 2022. PATIENT CLAIMS REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, INSTABILITY, AND COMPONENT LOOSENING. 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; Aseptic loosening; Discomfort; Failure of Implant; Insufficient Information; Joint Laxity; Pain

  MAUDE report 17085991 ↗