Optetrak Logic 02-010-03-0230Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862158017), received between Feb 15, 2020 and Aug 11, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K111400); 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Loosening of Implant Not Related to Bone-Ingrowth

  As reported, approximately 6 years and 6 months post the initial left total knee arthroplasty, the patient presented to the surgeon's office with stiffness, pain and dissatisfaction with their total knee. The patient has a recalled poly. The patient was revised to competitor devices. The femoral component was loose and not well fixed. Images provided show wear of the liner. There was no reported breakage of a device. There was a surgical delay/prolongation of 30-45 minutes due to switching to a total revision. The patient was last known to be in stable condition following the event.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 50208136 ↗
• InjuryJan 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, FAILURE OF IMPLANT, AND IMPLANT PAIN. INITIAL SURGERY AND 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: Failure of Implant; Implant Pain

  MAUDE report 21072408 ↗
• InjuryOct 31, 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

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 91 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DISCOMFORT, SWELLING, MOBILITY IMPAIRMENTS, BONE DETERIORATION, CYSTS; ONGOING MEDICAL CARE. INITIAL SURGERY AND 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; Bone Fracture(s); Cyst(s); Discomfort; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20578812 ↗
• InjuryJun 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY AND THEN APPROXIMATELY 4 YEARS, 8 MONTHS LATER WAS REVISED. 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. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: PAINFUL AND LOOSE LEFT TOTAL KNEE. ¿THE FEMUR, TIBIA AND PATELLA COMPONENTS WERE FOUND TO BE COMPLETELY LOOSE.¿ THE PATIENT'S BMI AND BODY MORPHOLOGY MADE THE REVISION CASE MORE DIFFICULT. THERE IS INCOMPLETE INFORMATION ON THE SURGICAL PROCEDURE WITHOUT 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; Joint Laxity; Pain

  MAUDE report 19630222 ↗
• InjuryNov 10, 2022Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, UNDERWENT A REVISION PROCEDURE ON THE LEFT KNEE, AND WAS REVISED TO A COMPETITOR¿S DEVICES. THE SURGEON NOTED THE POLY WAS LOOSE ON THE TRAY, THERE WAS NO EVIDENCE OF SUBSURFACE DELAMINATION, THERE WAS NO CEMENT FOUND ATTACHED TO THE FEMORAL COMPONENT WHEN REMOVED, THE ALIGNMENT OF PRIMARY COMPONENTS APPEARED FINE, THE FEMORAL COMPONENTS WERE LOOSE, THE TIBIAL COMPONENTS WERE WELL FIXED, AND THERE WERE SIGNS OF OSTEOLYSIS IN BOTH THE FEMUR AND TIBIA. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 15777562 ↗
• InjuryFeb 15, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6) NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2013. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A LOGIC - CRUCIATE RETAINING - CEMENTED FEMORAL COMPONENT - LEFT - SIZE 3 (CATALOG 02-010-03-0230, SERIAL (B)(4), LOGIC - FIT - CEMENTED TIBIAL TRAY - SIZE 3F/3T (CATALOG 02-012-45-3030, SERIAL (B)(4), LOGIC - CRUCIATE RETAINING TIBIAL INSERT - SIZE 3 11MM SLOPE + (CATALOG 02-012-48-3011, SERIAL (B)(4) AND STRYKER ANTIBIOTIC LOADED MEDIUM VISCOSITY BONE CEMENT (CATALOG 61971001, SERIAL (B)(4). ON (B)(6) 2018, APPROXIMATELY 59 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING PATELLA. THE EXACTECH WERE REMOVED AND REPLACED.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9715042 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013