Optetrak 208-21-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862054104), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

1 other recall cover devices cleared under the same FDA submission (K954208); 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.

• InjuryJul 27, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD THEIR FIRST LEFT KNEE REVISION SURGERY ON (B)(6) 2009. THEY SUBSEQUENTLY UNDERWENT ANOTHER LEFT KNEE REVISION ON (B)(6) 2016, APPROXIMATELY 7 YEARS AFTER THEIR FIRST REVISION. (B)(6) 2016 OP REPORT POSTOPERATIVE DIAGNOSIS: LEFT KNEE FAILED TOTAL KNEE REPLACEMENT WITH GROSS INSTABILITY. THE SURGEON NOTED THAT THE POLYETHYLENE HAD SOME EARLY WEAR AND WAS REMOVED. THE FEMORAL COMPONENT WAS REMOVED WITHOUT THE STEM, AND THE STEM WAS DISIMPACTED FROM THE FEMUR. THE TIBIAL COMPONENT COULD NOT BE DISENGAGED FROM THE STEM. A TIBIAL TUBERCLE OSTEOTOMY WAS REQUIRED, WHICH WAS PLANED PREOPERATIVELY. THE FRAGMENT FLIPPED LATERALLY. THE SURGEON ALSO NOTED THERE WAS A LARGE AMOUNT OF BONE MEDIALLY WHERE IT APPEARED THERE MAY BEEN A MEDIAL EPICONDYLAR FRACTURE THAT IT HEALED. THERE WAS ALSO SIGNIFICANT BONE LOSS AND SIGNIFICANT AMOUNT OF CEMENT, WHICH CREATED A LARGE VOID. THE PATELLA WAS NOTED TO HAVE MINIMAL WEAR, HOWEVER, THERE WAS MARKED OSTEOPHYTES SURROUNDING THE PATELLA. THE PATELLA WAS NOTED AS WELL FIXED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 17405378 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• 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-