Optetrak 244-24-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862064035), received between Oct 30, 2020 and Nov 1, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 204 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, REVISION SURGERY, OSTELYSIS, SYNOVITIS, EFFUSION, DELAMINATION OF THE POLYETHYLENE, LOSS OF MOBILITY, SWELLING AND PAIN. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20589889 ↗
• InjurySep 13, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4) RELATED CASE (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 20 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(6) 244-24-09 - OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 9MM SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH.

  Patient problems: Insufficient Information; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20215720 ↗
• InjuryJul 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 198 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR AND MAY REQUIRE A FUTURE REVISION PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; No Clinical Signs, Symptoms or Conditions; Osteolysis

  MAUDE report 19712138 ↗
• InjuryJul 10, 2024Unstable; Naturally Worn; Lack of Effect; Unstable; Naturally Worn; Lack of Effect

  IT WAS REPORTED THAT APPROXIMATELY 214 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Insufficient Information; Joint Laxity; Joint effusion; Loss of Range of Motion; Synovitis

  MAUDE report 19711737 ↗
• InjuryJul 10, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 197 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR OF TIBIAL INSERT AND PATELLA, OSTEOLYSIS, POLYETHYLENE DELAMINATION, EFFUSION, JOINT LAXITY, SYNOVITIS, AND FEMORAL COMPONENT LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANTS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Synovitis

  MAUDE report 19709992 ↗
• InjuryApr 26, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD AN INITIAL RIGHT KNEE REPLACEMENT ON (B)(6) 2007. APPROXIMATELY 9 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2016 DUE TO WORSENING PAIN AND SWELLING. IN OR ABOUT 2016, IMAGING DEMONSTRATED INTERVAL SUBSIDENCE OF THE TIBIAL COMPONENT CONSISTENT WITH LOOSENING OF THE COMPONENT. DURING THE REVISION SURGERY, THE PATIENT'S ORTHOPEDIC SURGEON STATED THAT THERE WAS OSTEOLYSIS NOTED AT THE DISTAL FEMUR ON THE LATERAL CONDYLE AND THE TIBIAL COMPONENT WAS GROSSLY LOOSE. PATHOLOGY CONFIRMED THAT THERE WAS A TISSUE REACTION TO THE POLYETHYLENE. UPON INFORMATION AND BELIEF, THE LOOSE COMPONENTS AND OSTEOLYSIS WERE DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE 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: Osteolysis

  MAUDE report 16814359 ↗
• InjuryMar 28, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THE MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2009. THE PATIENT WAS REVISED ON (B)(6) 2016 DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK POLYETHYLENE TIBIAL INSERT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Joint Laxity

  MAUDE report 16629957 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2007, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 15 YEARS POST THE INITIAL IMPLANT PROCEDURE FOR REASONS UNKNOWN.

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

  MAUDE report 15583931 ↗
• InjuryOct 30, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2006. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10760127 ↗

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