Optetrak Logic 02-012-45-5050Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862004055), received between Mar 11, 2024 and Jan 2, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 10 YEARS 8 MONTHS AFTER THEIR INITIAL PROCEDURE. PATIENT EXPERIENCED LOOSENING, JOINT LAXITY, IMPLANT PAIN, SYNOVITIS AND FAILURE OF IMPLANT. (B)(6) 2023 OP REPORT INTRAOPERATIVE FINDINGS INCLUDE LOOSE FEMORAL AND TIBIAL IMPLANTS - REMOVED EASILY WITH MODERATE BONE LOSS. THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE KNEE JOINT CONSISTENT WITH SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUE. THERE WERE TINY, SMALL BALLS OF LIGHT BROWN SYNOVIUM ALONG WITH A "PSEUDO-CAPSULE" OF DENSE SOFT TISSUE. THE SURGEON NOTED THERE WAS EXCESSIVE WEAR WITH SIGNS OF OXIDATION / YELLOW DISCOLORATION, PITTING, CRACKING, AND DELAMINATION OF THE POLYETHYLENE. DISTAL FEMORAL AND ANTERIOR FEMORAL BONE LOSS WAS MODERATE. TIBIAL BONE LOSS WAS EXTENSIVE AND REQUIRED PLACEMENT OF A TIBIAL CONE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Synovitis

  MAUDE report 21060193 ↗
• InjuryDec 13, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ (B)(6). (B)(4) IS ASSOCIATED WITH THIS CASE. 9/13/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 9/10/24. 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, 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 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 THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 7 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 IM

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

  MAUDE report 20925845 ↗
• InjuryDec 13, 2024Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  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, OSTEOLYSIS WITH CYSTIC FORMATION, BONE DEGRADATION, ASEPTIC LOOSENING, PAIN, FEMORAL LOOSENING, LOOSE TIBIAL BASEPLATE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Cyst(s); Failure of Implant; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 20923495 ↗
• InjuryOct 29, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 100 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO PROSTHESIS WEAR, ASEPTIC LOOSENING, SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Synovitis

  MAUDE report 20560123 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE 57 YEAR OLD MALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2015 AND PRESENTED WITH LUCENCY, 5 YEAR(S) AND 2 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2020. MINOR LUCENCY DETECTED ON X-RAYS, UNDER THE MEDIAL TIBIAL TRAY. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING AND THE REPORT INDICATES THAT THE ACTION TAKEN IS ACTIVE MONITORING WITH A REVIEW IN 12 MONTHS. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE ACTION TAKEN OF ACTIVE MONITORING WITH A REVIEW IN 12 MONTHS. THE OUTCOME IS CONTINUING. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Joint effusion; Osteolysis; Radiolucent Lines

  MAUDE report 18876679 ↗