Optetrak 244-25-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862064073), received between Feb 4, 2022 and May 14, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Unstable; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A PATIENT, WHO HAD A LEFT TKA SYSTEM WITH A 5 HI-FLEX FEMUR, 5 TIBIA, 35MM PATELLA, ALL CEMENTED AND A 9MM POLY SPACER, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED FOR EVALUATION WITH COMPLAINTS OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN. THE PATIENT WAS REVISED DUE TO IMPLANT LOOSENING, (FEMORAL LOOSENING, DEBONDED FROM CEMENT IN ONE GENTLE TAP), BONE LOSS AND SIGNIFICANT SYNOVITIS. THE WERE REVISED TO A COMPETITOR¿S DEVICES. FOLLOWING THE REVISION SURGERY, THE PLAINTIFF CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING, AND EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE WHICH LIMITS HIS ACTIVITIES AND IMPACTS HIS QUALITY OF LIFE. NO FURTHER INFORMATION. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 25178674 ↗
• MalfunctionMay 4, 2026Naturally Worn

  AS REPORTED BY THE LEGAL NOTIFICATION, A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY UTILIZING RECALLED EXACTECH COMPONENTS. NO REVISION SCHEDULED. BECAUSE THE PATIENT HAS FILED A LEGAL CLAIM, IT APPEARS THAT THEY ARE ALLEGING PROSTHESIS WEAR OF AN EXACTECH POLYETHYLENE DEVICE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25067816 ↗
• InjurySep 11, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2007. APPROXIMATELY 10 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2017 FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Emotional Changes; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 20197034 ↗
• InjuryJun 3, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 213 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS COMPONENT LOOSENING. PATIENT WAS PRESENTED WITH SIGNIFICANT PERIPROSTHETIC OSTEOLYSIS AND ASEPTIC LOOSENING OF THEIR RIGHT TOTAL KNEE ARTHROPLASTY WITH ASSOCIATED PAIN REFRACTORY TO COMPREHENSIVE NONOPERATIVE MANAGEMENT IN THE SETTING OF A RECALLED EXACTECH TOTAL KNEE DEVICE. DURING THE PROCEDURE IT WAS NOTED SEVERE REACTIVE SYNOVITIS AND JOINT EFFUSION CONSISTENT WITH POLYETHYLENE WEAR AND FEMORAL COMPONENT LOOSENING. THE PATELLAR BUTTON WAS ALSO INSPECTED AND DETERMINED TO BE LOOSE. 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; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 19454094 ↗
• InjuryApr 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2006, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2017 APPROXIMATELY 11 YEARS AND 5 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Inadequate Osseointegration; Muscle/Tendon Damage; Nerve Damage; Osteolysis; Pain

  MAUDE report 19132022 ↗
• InjuryNov 15, 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) 2009. APPROXIMATELY 12 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2021. 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 (B)(6) 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

  Patient problems: Insufficient Information

  MAUDE report 18140480 ↗
• InjuryNov 15, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  HOLD LY 11/16AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2009. APPROXIMATELY 11 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2021. 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

  Patient problems: Insufficient Information

  MAUDE report 18139699 ↗
• InjurySep 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT (B)(6) 2007. APPROXIMATELY 10 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2018. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES: PAIN, SUFFERING, LOOSENING OF THE IMPLANT, AND AN AVULSION MEDIAL EPICONDYLE FEMUR FRACTURE. 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. (B)(4), 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,

  Patient problems: Insufficient Information

  MAUDE report 17692021 ↗
• InjuryAug 4, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON 21 FEB 2006. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 16 YEARS 10 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2022 OP REPORT POSTOPERATIVE DIAGNOSIS: PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC LEFT KNEE JOINT. THE SURGEON NOTED A MODERATE AMOUNT OF REACTIVE SYNOVITIS WITH HEMOSIDERIN STAINING OF THE SYNOVIUM CONSISTENT WITH POLYETHYLENE WEAR AND INSTABILITY. THE FEMORAL COMPONENT DID NOT APPEAR GROSSLY LOOSE, BUT WAS EASILY EXPLANTED WITH GENTLE DISIMPACTION. THERE WAS NEARLY COMPLETE DE-BONDING OF THE FEMORAL COMPONENT WITH MINIMAL EVIDENCE OF AN IMPLANT-CEMENT INTERFACE. TIBIAL COMPONENT WAS NOTED AS WELL-FIXED. SURGEON FURTHER NOTED THERE WAS A LARGE CONTAINED CENTRAL DEFECT SECONDARY TO OSTEOLYSIS AS ANTICIPATED BASED ON PREOPERATIVE CT. PATELLAR COMPONENT WAS DETERMINED TO BE LOOSE. THE PATIENT EMERGED FROM ANESTHESIA AND WAS TRANSFERRED TO THE PACU IN STABLE CONDITION. 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: Inadequate Osseointegration; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 17461605 ↗
• InjuryMay 18, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF (B)(6), REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON 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 244-25-09-INSERTO TIB PS HI-FLEX 5, 9MM, SERIAL NUMBER (B)(6) ON (B)(6)2013. THE INSERT WAS MANUFACTURED ON 10/17/2011 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 10/17/2011 AND WAS 1.3689253935660506 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6)2022, APPROXIMATELY 9.0 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 16953076 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) MALE PATIENT HAS A 6-MONTH HISTORY OF RIGHT KNEE PAIN. PATIENT HAD A REVISION OF RIGHT KNEE COMPONENTS DUE TO PAIN AND INSTABILITY. PRIOR TO PATIENT REVISION, ON A PAIN SCALE, THE KNEE WAS RATED A 5/10 - 9/10 AND IS INTERMITTENT. THE PAIN WAS PARTICULARLY BAD WITH STANDING AND WALKING. THE PAIN WAS LOCATED ON THE INSIDE OF AND AT THE FRONT OF THE KNEE. THE PAIN WAS DESCRIBED AS SHARP. PATIENT COMPLAINED OF SWELLING AND INSTABILITY. AS OF MOST RECENTLY, THE PAIN WAS GETTING WORSE. HE UNDERWENT A RIGHT PRIMARY TKA (B)(6) 2009. HE INITIALLY HAD A VERY SMOOTH RECOVERY UNTIL ABOUT 5- OR 6-YEARS POST-OP WHEN HE DEVELOPED A SEVERE BAKER'S CYST. HE HAS HAD THESE DRAINED MULTIPLE TIMES INCLUDING A SURGICAL I&D, HOWEVER IT RETURNS AFTER BEING DRAINED. AS A RESULT, HE HAS HAD ONGOING PAIN WITH WEIGHTBEARING ACTIVITIES, PAIN AND INSTABILITY. THIS HAS SIGNIFICANTLY IMPACTED HIS QUALITY OF LIFE AND HAS AFFECTED HIS ABILITY TO PERFORM DAY TO DAY ACTIVITIES. HE NOTES THAT HIS SYMPTOMS HAVE SIGNIFICANTLY WORSENED, AS HE HAS BEEN BARELY ABLE TO WALK FOR THE PAST 1 MONTH.

  Patient problems: Pain

  MAUDE report 13455813 ↗

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