Optetrak Logic 02-012-44-2511Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862173522), received between Feb 21, 2022 and May 4, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENT, REVISION OPERATIVE REPORT, A PATIENT, HAD A FAILED RIGHT TOTAL KNEE REPLACEMENT REFRACTORY TO CONSERVATIVE MANAGEMENT. THE PATIENT WAS INDICATED FOR SURGERY. A THOROUGH SYNOVECTOMY WAS PERFORMED. THERE WAS A FRACTURE AT THE PROXIMAL TIP OF THE FEMORAL COMPONENT STEM WHICH WAS VISUALIZED AND CLEANED UP. THE FEMORAL FRACTURE WAS REDUCED WITH POINTED REDUCTION CLAMPS. FRESHENING CUTS WERE MADE TO THE FEMUR. THEY WERE ABLE TO OBTAIN AN ANATOMIC REDUCTION OF THE FRACTURE WHICH WAS STABLE WITH THE STRUT IN PLACE. THE FEMORAL IMPLANT WAS REMOVED WITH MINIMAL BONE LOSS. THE TIBIA WAS INTACT AND WELL FIXED. NEW FEMORAL COMPONENT AND INSERT WERE IMPLANTED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO MENTION OF ANY DEFECTS TO THE POLYETHYLENE LINER IN THIS OPERATIVE REPORT. 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. ADDITIONAL INFORMATION INDICATED THE PATIENT UNDERWENT SURGERY ON HER RIGHT KNEE AND WAS IMPLANTED WITH A RECALLED OPTETRAK POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(6). THE PATIENT UNDERWENT RIGHT KNE

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Discomfort; Joint Laxity; Osteolysis; Pain

  MAUDE report 25075746 ↗
• InjuryAug 28, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 31 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING AND INSTABILITY. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20087786 ↗
• InjuryJun 4, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 31 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY, AND POLYETHYLENE DEBRIS. 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; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19463440 ↗
• InjuryMay 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect

  IT WAS REPORTED THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SEVERE POLY WEAR ON THE ARTICULAR SURFACE, FEMORAL COMPONENT WAS LOOSE AND DEBONDED FROM THE CEMENT, PATELLAR COMPONENT HAD MILD WEAR. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Failure of Implant; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19374380 ↗
• InjuryOct 3, 2023Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2019. APPROXIMATELY 4 YEARS AND 2 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: PERIPROSTHETIC OSTEOLYSIS. CLEAR SYNOVIAL FLUID, WITHOUT SIGNS OF INFECTION. COMPLETE SYNOVECTOMY WAS PERFORMED ON THE MEDIAL AND LATERAL GUTTERS. THERE WAS SIGNIFICANT SYNOVITIS AND THE APPEARANCE OF WEAR PARTICLES IN THE SYNOVIUM BEHIND THE PATELLA. THE POLYETHYLENE INSERT WAS REMOVED AND EXTENSIVE WEAR OF THE POLY, PARTICULARLY IN THE POSTERIOR PORTION OF THE INSERT. THERE WERE SOME AREAS OF CONTAINED OSTEOLYSIS IN THE FEMORAL BONE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17859510 ↗
• InjurySep 7, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2014. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 8 YEARS 9 MONTHS POST PRIMARY PROCEDURE. THE PATIENT HAS CLAIMED THE FOLLOWING INJURIES AND COMPLICATIONS: SURGICAL REVISION AND OTHER MEDICAL TREATMENT, PAIN, SWELLING, STIFFNESS, LOSS OF MOTION, WEAKNESS, INSTABILITY, AND OTHER INJURIES AND/OR COMPLICATIONS. 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 POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE P

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

  MAUDE report 17698775 ↗
• InjuryAug 15, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2015. APPROXIMATELY 6 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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) 2022. DIAGNOSIS: FAILED RIGHT KNEE SECONDARY TO ACCELERATED WEAR OF THE TIBIAL POLYETHYLENE BEARING. THE RIGHT KNEE WAS ASPIRATED OF SYNOVIAL FLUID. A SUBTOTAL SYNOVECTOMY WAS PERFORMED REMOVING THE HYPERTROPHIC SYNOVIUM FROM THE SUPRAPATELLAR POUCH AND WORKING DOWN THE MEDIAL AND LATERAL GUTTERS. THERE WAS MODERATE TO SEVERE PITTING OF THE ARTICULAR WEIGHTBEARING SURFACES ON THE INSERT. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17548988 ↗
• InjuryMay 8, 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 REPLACEMENT ON (B)(6) 2015 . APPROXIMATELY 6 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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: Foreign Body Reaction; Insufficient Information; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16884761 ↗
• InjuryOct 18, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT WAS REVISED DUE TO WEAR AND LOOSENING AND THE TIBIAL INSERT AND BASEPLATE WERE REPLACED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 15623874 ↗
• InjuryFeb 21, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT SIDE TKA, THIS (B)(6) PATIENT PRESENTED TO SURGEON WITH SIGNIFICANT POLY WEAR WITH SIGNIFICANT OSTEOLYSIS. SURGEON PERFORMED A TOTAL REVISION KNEE. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS RECEIVED. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 13569775 ↗