Optetrak 204-24-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862048424), received between Oct 30, 2020 and May 9, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K933610); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED POLYETHYLENE WEAR, PAIN, SWELLING, AND DISCOMFORT. THERE WAS NO INFORMATION PROVIDED ABOUT A REVISION PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Implant Pain; Pain; Swelling/ Edema

  MAUDE report 19277645 ↗
• InjuryApr 28, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL TEAM, PATIENT ORIGINAL SURGERY WAS PERFORMED BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6) IN 2014. PATIENT MOVED FROM (B)(6) TO (B)(6) AFTER THE PRIMARY SURGERY. PATIENT HAS HAD TWO (2) REVISIONS IN (B)(6) AT (B)(6) MEDICAL CENTER WITH A DR. (B)(6) SAYS HAD PAIN AND ISSUES FOLLOWING THE PRIMARY SURGERY. WHEN PATIENT HAD FIRST REVISION IN 2017, THE SURGEON CORRECTED A ¿PATELLAR ISSUE¿ (THE PATELLAR BUTTON WAS LOOSE HE THOUGHT), AND ¿TIGHTENED THE KNEE¿. HOWEVER, ONLY THE INSERT WAS EXCHANGED. THE PATIENT CONTINUING PAIN AND MOBILITY ISSUES, THEN IN (B)(6) 2021 HAD A SECOND REVISION. PATIENT BELIEVES ALL THE COMPONENTS WERE REMOVED IN 2021, AND SURGEON SAID HE HAD SIGNIFICANT LYSIS. PATIENT HAS HAD TO WORK FROM HOME SINCE THE SURGERY, HAS LEG LENGTH ISSUES, CONTINUING PAIN, ETC. PATIENT IS MALE, (B)(6) AND HAS VERY LIMITED MOBILITY.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 14244061 ↗
• 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) 2010. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10760090 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933610. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-
• Z-2070-2012 · Sep 23, 2011 · Terminated
  Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 2
• Z-0347-05 · Nov 11, 2004 · Terminated
  Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.