Optetrak 244-22-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862063960), received between Apr 12, 2023 and May 6, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 224 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PAIN, SWELLING, LOOSENING, INSTABILITY, DIFFICULTY WALKING, POLYETHYLENE DEGRADE, LOOSE POLYETHYLENE PARTICLES IN THE KNEE CAVITY AND SURROUNDING TISSUES, POLYMERIC INDUCED SYNOVITIS FROM THE POLYETHYLENE COMPONENT, DESTRUCTION AND REABSORPTION OF THE BONE AND SURROUNDING TISSUE OF THE KNEE CAVITY. APPROXIMATELY 140 MONTHS POST INDEX PROCEDURE, THE PATIENT WAS CLINICALLY OBSERVED TO BE DISPLAYING PAIN AND SWELLING IN THE RIGHT KNEE AND A SUBSEQUENT MRI INDICATED BILATERAL POLYMERIC-INDUCED SYNOVITIS FROM THE POLYETHYLENE DEGRADING IN BOTH IMPLANTS. THE LEFT KNEE REVISION PROCEDURE WAS REPORTED IN A SEPARATE EVENT. APPROXIMATELY 160 MONTHS POST-INDEX, THE PATIENT EXPERIENCED BILATERAL PAIN. A 2ND MRI 162 MONTHS POST-INDEX INDICATED SIGNIFICANT DEBRIS SYNOVITIS IN THE RIGHT KNEE. THE SURGEON ADVISED THAT SHE WOULD NEED TO UNDERGO A REVISION SURGERY ON THE RIGHT KNEE. AT THE TIME OF LEGAL NOTIFICATION, NO KNOWN REVISION OR PLANNED REVISION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 21971785 ↗
• InjuryJun 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 127 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19575486 ↗
• InjuryMay 23, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, 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 244-22-11-INSERTO TIB PS HI-FLEX 2, 11MM, SERIAL NUMBER (B)(6) ON (B)(6)2012. THE INSERT WAS MANUFACTURED ON 2/4/2011 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 2/4/2011 AND WAS 0.95550992470910334 YEARS SHELF AGE AT THE TIME OF IMPLANT. PENDING REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16988863 ↗
• InjuryMay 4, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  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 ON 15 DEC 2016 WITH ANOTHER EXACTECH KNEE SYSTEM. APPROXIMATELY 6 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND LEFT KNEE REVISION ON (B)(6) 2017 WITH ANOTHER EXACTECH KNEE SYSTEM. APPROXIMATELY 4 YEARS AND 1 MONTH AFTER THE SECOND REVISION THE PATIENT HAD A THIRD LEFT KNEE REVISION ON (B)(6) 2021. AFTER EACH OF THE LEFT TOTAL KNEE REPLACEMENT SURGERIES, PLAINTIFF BEGAN TO SUFFER FROM SYMPTOMS ASSOCIATED WITH THE DEFECTS OF EXACTECH KNEE SYSTEM AS ALLEGED IN THIS COMPLAINT, 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.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16869954 ↗
• InjuryMay 4, 2023Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, ON (B)(6) 2014, THIS PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY AND WAS IMPLANTED WITH AN EXACTECH KNEE SYSTEM. AFTER THE LEFT TOTAL KNEE REPLACEMENT SURGERY, THE PATIENT BEGAN TO SUFFER FROM SYMPTOMS INCLUDING BUT NOT LIMITED TO INSTABILITY AND LOOSENING, PAIN AND LACK OF MOBILITY. AS A RESULT OF THESE SYMPTOMS, PATIENT UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2016, APPROXIMATELY 2 YEARS 4 MONTHS AFTER THEIR INITIAL REPLACEMENT. 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.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Failure of Implant; Joint Laxity; Pain; Synovitis

  MAUDE report 16867894 ↗
• InjuryApr 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  LEGAL CASE - USA. THIS PATIENT HAD ORIGINAL RIGHT KNEE IMPLANT (B)(6) 2010. THE PATIENT RECENTLY HAD RIGHT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 12 YEARS, 4 MONTHS AFTER INITIAL IMPLANT. EBI INITIAL SURGERY - ATTACHED. (B)(4) 244-22-11 - OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 11MM. SERIAL NUMBER 1473735 IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. PMA/510K: K033883. CONCOMITANT MEDICAL PRODUCTS: AA3614 13A2101 - CEMEX SYSTEM FAST GENTA 70G. 1523454 200-02-29 - THREE PEG PATELLA 29MM. 1740798 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T. 1693834 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK). 98179 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050). 1739984 244-03-02 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 16728288 ↗

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