Optetrak Logic 02-012-35-3515Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862001870), received between Feb 19, 2022 and Apr 19, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

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

1 other recall cover devices cleared under the same FDA submission (K093360); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2023Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  LEGAL CASE GREGORY TOSKOS RK REV AS REPORTED VIA LEGAL DOCUMENTATION, THIS 47 YEAR OLD MALE UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2015 FOR SPORTS RELATED SEVERE POSTTRAUMATIC ARTHRITIS. HE DID WELL INITIALLY, BUT APPROXIMATELY 2 YEARS POSTOPERATIVELY, HE BEGAN TO PRESENT WITH COMPLAINTS OF SWELLING RELATED TO ACTIVITY IN THE RIGHT KNEE. WITH EXERCISE, SKATING OR OTHER ACTIVITIES, THE KNEE BECAME PROMINENTLY SWOLLEN AND THIS PROGRESSED OVER TIME SO THAT OVER THE LAST YEAR AND A HALF, THE SWELLING WAS BECOMING UNCOMFORTABLE AND MANIFESTING IN SEVERE STIFFNESS AND LOSS OF MOTION. THE PATIENT DID RECEIVE A RECALL LETTER IN EARLY 2022, AND WE THEREFORE BROUGHT HIM IN, ANALYZED THE JOINT FLUID, WHICH WAS CONSISTENT WITH ACCELERATED POLYETHYLENE WEAR, AND INFECTION, BUT VERY THICKENED AND HYPERTROPHIC SYNOVIAL SOFT TISSUES. THE PATIENT UNDERWENT REVISION RIGHT TOTAL KNEE REPLACEMENT, TIBIAL COMPONENT WITH POLYETHYLENE EXCHANGE (B)(6) 2022, APPROXIMATELY 7 YEARS AFTER THEIR INITIAL REPLACEMENT. PRE & POST OPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO PREMATURE WEAR OF THE BEARING SURFACE. SURGEON NOTED THAT THE POLYETHYLENE INSERT SHOWED CONSIDERABLE WE

  Patient problems: Failure of Implant; Implant Pain; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 16769402 ↗
• InjuryMar 3, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  REVISION OP REPORT OF 4 MAY 2017-FINDINGS: THERE WAS FOUND TO BE POLYETHYLENE WEAR OF THE TIBIAL COMPONENT WITH CREEP OF THE POSTERIOR POLYETHYLENE AS WELL AS WEAR OF THE TIBIAL POST. THERE WAS SLIGHT VARUS/VALGUS LAXITY WITH THE EXISTING COMPONENT. THE FEMORAL COMPONENT AND TIBIAL COMPONENTS THEMSELVES WERE FOUND TO BE WELL FIXED. THE PATELLA WAS FOUND TO BE SOMEWHAT UNDERSIZED WITH BONY OVERGROWTH. THIS WAS REVISED. ULTIMATE RECONSTRUCTION WITH A 17 MM POLYETHYLENE ALLOWED FULL EXTENSION, NO RECURVATUM, FLEXION OF 125 DEGREES WITH EXCELLENT STABILITY AND EXCELLENT TRACKING. STERILE BANDAGES WERE APPLIED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 16478431 ↗
• InjuryFeb 19, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL TKA, THIS (B)(6) MALE PATIENT COMPLAINED OF PERSISTENT PAIN ASSOCIATED WITH TOTAL KNEE. PATIENT HAD A REVISION OF TOTAL KNEE. THE LINER WAS EXCHANGED. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PICTURES OF LINER ARE AVAILABLE. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THEY WERE LOST/DISPOSED OF DURING STERILIZATION PROCESS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13565340 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093360. One submission often covers many models, so check the product and lot details in each record.

• Z-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ