Optetrak 200-63-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862041074), received between Oct 31, 2022 and Dec 9, 2024 — 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.

5 other recalls cover devices cleared under the same FDA submission (K932690); 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.

• InjuryDec 9, 2024Fracture; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 101 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INCREASED PAIN AND MECHANICAL SYMPTOMS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED WEAR, LOOSENING AND FRACTURE OF THE POLYETHYLENE LINER AND LOOSENING OF THE FEMORAL COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 20888195 ↗
• InjuryAug 22, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE SURVEILLANCE OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND HEALTH PRODUCTS, PATIENT HAD POOR CLINICAL EVOLUTION LEADING TO EARLY REPLACEMENT OF KNEE PROSTHESIS IMPLANTED ON (B)(6) 2017. THE TIBIAL INSERT WAS DETERIORATED WHEN REMOVED, IT WAS AFFECTED BY THE HEALTH ALERT SENT BY THE COMPANY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Discomfort; Failure of Implant; Inflammation; Joint Laxity; Joint effusion

  MAUDE report 17595886 ↗
• InjuryMar 28, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THE MALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2012. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 SECONDARY TO POLYETHYLENE LINER WEAR WITH SEVERE OSTEOLYSIS AND ASEPTIC. LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 16633194 ↗
• InjuryMar 24, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED FROM THE LEGAL DEPARTMENT THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT WITH AN EXACTECH KNEE DEVICE. ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION OF THE LEFT EXACTECH KNEE DEVICE SECONDARY TO CATASTROPHIC POLYETHYLENE LINER WEAR AND FAILURE WITH RESULTING METALLOSIS, OSTEOLYSIS, AND SYNOVITIS; APPROXIMATELY 4 YEARS, 9 MONTHS AFTER IMPLANT. IT IS ALSO STATED THAT DESPITE UNDERGOING THE REVISION SURGERY, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. 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; Balance Problems; Discomfort; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 16608683 ↗
• InjuryOct 31, 2022Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF, ON OR ABOUT (B)(6) 2011, PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS IN HIS LEFT KNEE. DURING THE PROCEDURE. SUBSEQUENTLY, ON OR ABOUT (B)(6) 2012, PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS IN HIS RIGHT KNEE. ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY DUE TO A FAILED LEFT TOTAL KNEE ARTHROPLASTY. SURGEON DICTATED IN HIS OPERATIVE PATHOLOGY FINDING THAT "THE PATIENT HAD SIGNIFICANT POLYETHYLENE WEAR ON THE TIBIAL SURFACE." MOREOVER, SURGEON INDICATED "THERE WAS GROSS OSTEOLYTIC DEBRIS. THE TIBIAL BASEPLATE WAS EASILY EXTRACTED AND FRANKLY LOOSE. THE FEMORAL COMPONENT, ALTHOUGH WELL FIXATED, UPON REMOVAL, THERE WAS A SIGNIFICANT OSTEOLYTIC NON-CONTAINED CAVITARY DEFECT THAT EXTENDED INTO THE POSTERIOR CONDYLE." SURGEON REVISED THE EXACTECH COMPONENTS OF THE PATIENT'S LEFT KNEE IMPLANT AND IMPLANTED A COMPETITORS COMPONENTS.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Failure of Implant; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 15698684 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932690. One submission often covers many models, so check the product and lot details in each record.

• Z-2157-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
• Z-2155-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
• Z-2156-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
• Z-2158-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-