Optetrak Logic 02-012-47-5009Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10885862174543), received between Sep 21, 2020 and Aug 1, 2025 — classified as 23 injuries.

The most frequently reported specific device problem is “Naturally Worn” (20 reports).

2 FDA recall records name this device's identifier, 2 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. Nov 21, 2023Class IIOpen, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0583-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

2. 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2025Fracture; Peeled/Delaminated; Naturally Worn; Fracture; Peeled/Delaminated; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS AND 2 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE POLY INSERT AND PATELLA WERE REVISED FOR FAILURE OF THE COMPONENTS AND WEAR. THE INSERT HAD DELAMINATED AND CRACKED. SEVERAL PIECES WERE RECOVERED. THE IMPLANTS WERE REPLACED WITH VIT E IMPLANTS. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 22686685 ↗
• InjuryJul 30, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, WHO HAD AN INITIAL KNEE IMPLANT, UNDERWENT A REVISION PROCEDURE. POLYETHYLENE WEAR WITH JOINT INFLAMMATORY REACTION AND OSTEOLYSIS AT THE BONE-PROSTHESIS INTERFACE WAS INDICATED. ADDITIONALLY STATED ¿NEED FOR SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. SIGNIFICANT DISABILITY.¿ NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s); Inflammation; Muscular Rigidity; Osteolysis; Pain

  MAUDE report 22661162 ↗
• InjuryMar 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 65 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21552803 ↗
• InjuryAug 23, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS POST OP INITIAL LEFT TSA, THIS 60 Y/O MALE PATIENT WAS REVISED. THE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING AND OSTEOLYSIS AS A RESULT OF POLY WEAR. THE PATIENT WAS REVISED TO A SIZE 5 FEMORAL COMPONENT AND A SIZE 5 13MM TIBIAL INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 20057238 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 46 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE LINER WAS REPLACED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF BY THE CUSTOMER. NO X-RAYS OR DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19645140 ↗
• InjuryJun 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 77 MONTHS AFTER A LEFT 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 19470554 ↗
• InjuryJun 4, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 102 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, DECREASED RANGE OF MOTION, EFFUSION, OSTEOLYSIS AND BONE LOSS. 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: Ankylosis; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint effusion; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 19459388 ↗
• InjuryJun 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 109 MONTHS AFTER A LEFT 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 19458602 ↗
• InjuryJan 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED A 74 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 6 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PATELLA WEAR AND DELAMINATION. THE FEMUR COMPONENT WAS REVISED TO A SIZE 5 FEMORAL COMPONENT AND THE TIBIAL INSERT WAS REVISED TO A SZ 5, 9MM TIBIAL INSERT. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO THE CUSTOMER DISCARDED THEM. PHOTOS OF THE EXPLANTS WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18440112 ↗
• InjuryNov 22, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR AND FEMUR LOOSENING. 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; Insufficient Information

  MAUDE report 18197019 ↗
• InjuryOct 31, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 4 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2021. 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 APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Emotional Changes; Insufficient Information; Pain

  MAUDE report 18039018 ↗
• InjuryAug 31, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2015. DEVICE HAS NOT BEEN EXPLANTED. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN AND DISCOMFORT. THE PATIENT HAS SUFFERED DEBILITATING INJURES AND DAMAGES, 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 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, 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 PREMAT

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 17661946 ↗
• InjuryAug 31, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 7 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE. THE PATIENT HAS SUFFERED DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT, SWELLING, GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE. 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, 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 POLYETHYL

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

  MAUDE report 17661614 ↗
• InjuryAug 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST OP INITIAL RIGHT TKA, THIS 72 Y/O MALE PATIENT WAS REVISED. SURGEON PERFORMED A POLY SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNKNOWN MEDICAL HISTORY. NO X-RAYS OR IMAGES OF PRODUCT PROVIDED. DUE TO HOSPITAL KEEPING PRODUCT IT WILL NOT BE RETURNED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17563621 ↗
• InjuryJun 21, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT 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 17177549 ↗
• InjuryJun 8, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2022. THE PATIENT PRESENTED TO THE SURGEON WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY AND DISSATISFACTION WITH THEIR LEFT TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS. A COMPLETE REVISION. THE PATIENT WAS REVISED ON (B)(6) 2023. THE POLY AND PATELLA IMPLANTS WERE 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: Discomfort; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17094837 ↗
• InjuryJun 2, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2015. THEIR LEFT KNEE WAS REVISED ON (B)(6) 2022, APPROXIMATELY 7 YEARS 4 MONTHS AFTER THEIR INITIAL REPLACEMENT. THE REASON FOR REVISION HAS NOT BEEN PROVIDED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Insufficient Information; Osteolysis

  MAUDE report 17052591 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 69 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A POLY EXCHANGE ON (B)(6) 2023, APPROXIMATELY 5 YEARS 2 MONTHS POST THE INITIAL PROCEDURE, REASON FOR THE REVISION IS UNKNOWN. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED DUE TO THE HOSPITAL WOULD NOT ALLOW. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 16508662 ↗
• InjuryJan 4, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, WAS REVISED ON (B)(6) 2022, APPROXIMATELY 2 YEARS 10 MONTHS POST THE INITIAL PROCEDURE DUE TO POLY WEAR. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING AS IT WAS DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16099186 ↗
• InjuryJan 4, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2020, WAS REVISED ON (B)(6) 2022, APPROXIMATELY 2 YEARS 10 MONTHS POST THE INITIAL PROCEDURE DUE TO POLY WEAR. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING AS IT WAS DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16099073 ↗
• InjuryNov 2, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL DEPARTMENT, APPROXIMATELY 7 YEARS POST OP THE LEFT INITIAL TKA, THIS MALE PATIENT WAS REVISED. THE PATIENT HAS SUFFERED WITH SEVERE PAIN, INFLAMMATION, AND OSTEOLYSIS, AMONG OTHER THINGS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 15713690 ↗
• InjuryApr 8, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY ONE YEAR POST INITIAL LEFT TKA, THIS(B)(6) MALE PATIENT HAD A REVISION DUE TO INCREASE WEAR OF THE POLYETHYLENE INSERT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14053556 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2 WEEKS AFTER THE INITIAL LEFT TKA, FOR THIS (B)(6) Y/O MALE PATIENT, THE STITCHES ON THE LEFT KNEE WERE SPLITTING SO THEY DECIDED TO DO A WASH OUT AND REPLACE THE LINER. INFECTION WAS NOTED DURING THE WASHOUT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 10561284 ↗