Optetrak 244-03-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862063830), received between Nov 25, 2019 and Mar 9, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryMar 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 10 YEARS POST INITIAL RIGHT TKA, THIS (B)(6) FEMALE PATIENT WAS BROUGHT BACK WITH RIGHT KNEE PAIN. BONE SCAN SUGGESTED LOOSENING TO BOTH THE FEMORAL AND TIBIAL COMPONENTS. THE INSERT WAS REMOVED WITH SIGNS OF WEAR. THE TIBIA WAS CHECKED AND FOUND TO BE LOOSE AND REMOVED. THE FEMUR CHECKED AND REMOVED AS WELL. DUE TO THE LARGE AMOUNT OF BONE LOSS ON THE FEMUR, THE PATIENT RECEIVED A COMPETITOR'S DISTAL FEMORAL KNEE REPLACEMENT. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS A 45 MINUTE SURGICAL DELAY/PROLONGATION. THIS TURNED INTO A MORE COMPLICATED SURGERY THAN EXPECTED DUE TO OSTEOLYSIS TO THE FEMUR AND TIBIA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND PHOTOS RECEIVED. THE DEVICES WILL BE RETURN. AS PER SURGEON: "THIS TURNED INTO A MORE COMPLICATED SURGERY THAN EXPECTED DUE TO OSTEOLYSIS TO THE FEMUR AND TIBIA."

  Patient problems: Failure of Implant

  MAUDE report 13713029 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 10 YEARS AFTER INITIAL IMPLANT, THE 53 Y/O FEMALE PATIENT WAS REVISED. THE PATIENT WAS REVISED FOR ASEPTIC LOOSENING.. DEVICES NOT RETURNING AS THEY WERE RETAINED BY THE PATIENT. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 9369082 ↗

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