Optetrak 244-22-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862063953), received between Mar 30, 2023 and Jul 14, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 reports).

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

3 other recalls cover devices cleared under the same FDA submission (K033883); 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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0019-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryJul 14, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 13 YEARS POST THE INITIAL TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO AN INTERCONDYLAR FRACTURE WITH TIBIAL OSTEOLYSIS, AND LOOSENING OF THE FEMORAL COMPONENT. POLYETHYLENE ASYMMETRY WAS OBSERVED. THE PATIENT WAS REVISED TO COMPETITOR PRODUCTS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 22493146 ↗
• InjuryJan 24, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA. PATIENT ID: (B)(6). CASE-(B)(4). CASE-(B)(4). ***ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 14-NOV-2023 4 JAN 2024, (B)(6) , RN- IMPLANT DATE: (B)(6) 2010, , OP REPORT ATTACHED / EXPLANT DATE: (B)(6) 2016: POSTOPERATIVE DIAGNOSIS: SYNOVITIS, WITH ASEPTIC LOOSENING; OPEN DEBRIDEMENT AND SYNOVECTOMY WITH REVISION OF ALL 3 COMPONENTS. REVISED TO EXACTECH DEVICES. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY IN STABLE CONDITION. REVISION OP REPORT ATTACHED. ***ORIGINAL DESCRIPTION SUMMARY*** AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2010. APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD THE FIRST LEFT KNEE REVISION. AFTER EACH OF THE LEFT TOTAL KNEE REPLACEMENT SURGERIES, THE PATIENT BEGAN TO SUFFER FROM SYMPTOMS INCLUDING BUT NOT LIMITED SO SYNOVITIS WITH ASEPTIC LOOSENING, MECHANICAL LOOSENING, PAIN AND LACK OF MOBILITY. 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 DEV

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain; Synovitis

  MAUDE report 21233372 ↗
• InjuryMay 20, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 9 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY, ASEPTIC LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 19354983 ↗
• InjuryJun 26, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY REVISION ON (B)(6) 2019 AND THEN APPROXIMATELY 3 YEARS LATER HAD A SECOND SURGICAL REVISION ON (B)(6) 2022. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. SECOND REVISION OPERATIVE REPORT ON (B)(6) 2022. PRELIMINARY DIAGNOSIS: 1. RECALL RIGHT KNEE IMPLANT 2. OSTEOLYSIS RIGHT KNEE. INDICATION: PATIENT BEGAN DEVELOPING INCREASING PAIN. POSTOPERATIVE DIAGNOSIS: LOOSENING/DEBONDING RIGHT FEMORAL IMPLANT RIGHT KNEE. PROCEDURE: THE FEMUR WAS NOTED TO BE WELL FIXED. BECAUSE OF MRI IMAGING FINDINGS A DECISION WAS MADE TO REMOVE THE FEMUR. THE TIBIA WAS NOTED TO BE WELL FIXED. DEVICES WERE THEN IMPLANTED. A STERILE COMPRESSIVE DRESSING WAS APPLIED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY ROOM AND THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. HOSPITAL CARE: ADMITTED (B)(6) 2022/DISCHARGED (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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Synovitis

  MAUDE report 17198179 ↗
• InjuryMar 30, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT THIS PATIENT UNDERWENT REVISION LEFT KNEE REPLACEMENT. PRE OP DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY WITH ASEPTIC LOOSENING. POST OP DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE FAILURE, METALLOSIS AND ASEPTIC LOOSENING. UPON ENTERING THE JOINT, THERE WAS DIFFUSE SEVERE METALLOSIS. A SYNOVECTOMY WAS PERFORMED. SPECIMEN WAS SENT TO PATHOLOGY FOR FROZEN SECTION, ALTHOUGH NO VISIBLE SIGN OF INFECTION. THE PATELLAR COMPONENT WAS INSPECTED AND GROSSLY LOOSE WITH METALLOSIS AND PRESENT WITH POCKETS OF DEFECT IN THE PATELLA, THE PATELLAR COMPONENT WAS REMOVED WITH OSCILLATING SAW. THE FEMORAL COMPONENT WAS REMOVED WITH EASE WITH OSTEOTOMES. NO BONE WAS LOST WITH REMOVING THE FEMORAL COMPONENT. THE TIBIAL COMPONENT WAS ALSO REMOVED WITH EASE. THERE WAS NOTED TO BE SIGNIFICANT METALLOSIS WITH NECROTIC TISSUE POSTERIORLY, POSTERIOR MEDIAL AND LATERALLY AS WELL AS A LARGE BONY DEFECT ENCOMPASSING ALMOST THE WHOLE LATERAL FEMORAL CONDYLE. THIS AREA WAS CURETTED OUT AND DEBRIDED TO GOOD BLEEDING BONE. THE WOUND WAS VIGOROUSLY IRRIGATED AND FREED OF AS MUCH METALLOSIS AND SYNOVITIS, I COULD SAFELY REMOVE. THERE WAS STILL SOM

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Metal Related Pathology; Pain; Synovitis; Tissue Breakdown

  MAUDE report 16650012 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants