Optetrak 244-21-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862063915), received between May 19, 2023 and May 19, 2023 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 59 Y/O PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 6 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2017, DUE TO SEVERE ARTICULAR SURFACE WEAR. REVISION OPERATIVE REPORT RIGHT KNEE OF (B)(6) 2017. DIAGNOSIS: PERIPROSTHETIC OSTEOLYSIS AND ARTICULAR SURFACE WEAR. MULTIPLE PIECES OF DELAMINATED POLYETHYLENE WAS REMOVED. THERE WAS SEVERE DELAMINATION OF THE CONDYLAR SURFACES OF THE TIBIA, BOTH MEDIAL AND LATERAL. THERE WAS SIGNIFICANT DEFORMATION OF THE PS POST. THERE WERE SEVERAL AREAS OF UNCONTAINED OSTEOLYSIS, BOTH IN THE METAPHYSIS AND IN THE LATERAL CONDYLE. THERE WAS A VERY LARGE AREA OF OSTEOLYTIC DEBRIS, DEEP TO THE TIBIAL TUBERCLE. STERILE DRESSINGS WERE APPLIED. THE PATIENT WAS AWOKEN AND TAKEN TO POSTOPERATIVE CARE UNIT IN GOOD CONDITION WITHOUT COMPLICATION.

  Patient problems: Failure of Implant; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 16962378 ↗

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