Optetrak 244-23-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862064004), received between Oct 15, 2020 and Jul 6, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2026Unstable; Naturally Worn

  REPORT #2 OF 4 FOR THIS EVENT. IT WAS REPORTED A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, SWELLING AND INSTABILITY. AS A RESULT, EIGHT (8), YEARS, FIVE (5) MONTHS LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE. A REVISION OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS WAS NOTED AS ASEPTIC LOOSENING, RIGHT TOTAL KNEE ARTHROPLASTY. INTRAOPERATIVELY, IT WAS NOTED THE FEMORAL, TIBIAL AND PATELLA COMPONENTS WERE SIGNIFICANTLY LOOSE. SYNOVITIS WAS EVIDENT. THE PATIENT WAS TRANSFERRED TO PATIENT AFTER CARE UNIT IN STABLE CONDITION. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAS EXPERIENCED AND CONTINUES TO EXPERIENCE PAIN, DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS AND OTHER INJURIES PRESENTLY UNDIAGNOSED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Erosion; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 25717729 ↗
• InjurySep 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 173 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN; EFFUSION, SEVERE SYNOVITIS AND OSTEOLYSIS; FEMORAL AND TIBIAL LOOSENING; DISCOLORATION AND DELAMINATION OR BREAKAGE ON THE TIBIAL INSERT, POSSIBLE DEFECT OF THE PATELLA POLYETHYLENE. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20212563 ↗
• InjuryAug 23, 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 THAT APPROXIMATELY 175 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SEVERE OSTEOLYSIS AND DESTRUCTION OF HER DISTAL FEMORAL METAPHYSIS AS WELL AS SIGNIFICANT PAIN, INSTABILITY, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20044989 ↗
• InjuryApr 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2014 APPROXIMATELY 2 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19094944 ↗
• InjuryDec 20, 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)2008. APPROXIMATELY 10 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON 30 JUN 2018. 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 COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO.(B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR

  Patient problems: Insufficient Information

  MAUDE report 18365811 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2007. APPROXIMATELY 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2008. 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) 2008. DIAGNOSIS: PAINFUL RIGHT REPLACEMENT THE KNEE WAS ASPIRATED AND 20CC OF YELLOWISH, RED KNEE FLUID. NO INFECTION. THE TIBIA APPEARED TO BE A LITTLE TOO LARGE. THERE WAS A LITTLE OVERHANG IN THE FRONT AND AT THE ANTEROMEDIAL CORNER ALSO AN OVERHANG ON THE LATERAL ASPECT AS WELL. THE TIBIAL BASE PLATE APPEARED TO BE JUST SLIGHTLY INTERNALLY ROTATED. A TRIAL REDUCTION WAS DONE. THE STERILE DRESSINGS WERE APPLIED. THERE WERE NO COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Implant Pain

  MAUDE report 17652362 ↗
• InjuryMay 21, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT (B)(6) WAS IMPLANTED WITH A 244-23-11-INSERTO TIB PS HI-FLEX 3 ,11MM, SERIAL NUMBER (B)(6), ON (B)(6) 2012. THE INSERT WAS MANUFACTURED ON (B)(6) 2011, AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON (B)(6) 2011 AND WAS ONE YEAR SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2015, APPROXIMATELY THREE YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16971076 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL TOLLING AGREEMENT, THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 8 YEARS 3 MONTHS POST THE INITIAL PROCEDURE FOR REASONS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393585 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2013, DUE TO OTHER CONDITIONS (UNSPECIFIED FAILURE). INITIAL SURGERY DATE WAS (B)(6) 2008. THIS PATIENT HAD BILATERAL KNEE ARTHROPLASTY, THE REVISION SIDE IS NOT REPORTED; THE LEFT SIDE DEVICES HAVE BEEN USED FOR THIS COMPLAINT INVESTIGATION. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10775742 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2010, DUE TO A BONE FRACTURE. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10687547 ↗

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 Inser
• 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