Optetrak 244-03-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862063861), received between Feb 13, 2020 and Nov 9, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2014, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2006. THE PATIENT HAD BILATERAL KNEE SURGERY. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10808452 ↗
• InjuryFeb 13, 2020Naturally Worn; Naturally Worn

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2019, APPROXIMATELY 120 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OSTEOLYSIS (LYSISFEMUR &LYSISTIBIA) AND WEAR OF POLYETHYLENE COMPONENT. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. IT IS FOUND IN A REVIEW OF THE LABELING AND IFU 700-096-004, OSTEOLYSIS IS A KNOWN DEVICE SPECIFIC RISK, WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. IT IS KNOWN THAT BONE MINERAL DENSITY AT A TOTAL KNEE ARTHROPLASTY WILL DECREASE WITHIN SEVERAL MONTHS POST IMPLANT. BONE LOSS DENSITY CAN REACH ABOUT 23% WITHIN ONE YEAR OF THE POST-OP PERIOD. VALUES ARE DEPENDENT ON THE PREOPERAT

  Patient problems: Failure of Implant

  MAUDE report 9709805 ↗

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