Optetrak Logic 02-012-65-5017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862266262), received between Nov 21, 2023 and Jul 2, 2024 — classified as 2 injuries.

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.

4 other recalls cover devices cleared under the same FDA submission (K150890); 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-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 70 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED PROSTHESIS WEAR, JOINT PAIN, SWELLING AND STIFFNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 19655644 ↗
• InjuryNov 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 71 Y/O MALE PATIENT RECEIVED KNEE IMPLANT FOLLOWING A SPACER REMOVAL ON (B)(6) 2023. SURGEON WANTED TO CHECK AND MAKE SURE THE WOUND WASN'T DRAINING INTO THE CAPSULE AND WANTED TO WASH IT OUT. SURGEON THEN DECIDED TO SWAP OUT THE 5 X 17MM CC POLY FOR A NEW ONE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO IMAGES OR X-RAYS AVAILABLE. DEVICES ARE NOT RETURNING - HOSPITAL DOESN'T RELEASE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18181572 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150890. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
• Z-1364-2020 · Jan 27, 2020 · Open, Classified
  Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, s
• Z-3209-2018 · May 8, 2018 · Open, Classified
  Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total k
• Z-2704-2017 · Apr 7, 2017 · Terminated
  Exactech Optetrak Logic CC 15mm Tibial Augment Screws