Optetrak Logic 02-012-35-6009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862001962), received between Dec 1, 2022 and Jul 25, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS AND 2 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT, AND THE FEMORAL COMPONENT DEBONDED FROM THE CEMENT. EVERYTHING WAS REMOVED AND REPLACED WITH COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19826856 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2021, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022, APPROXIMATELY 1 YEAR, 3 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19280508 ↗
• InjuryJan 17, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA MEDWATCH (REF# MW5147862), PATIENT HAD KNEE REPLACEMENT DONE THREE YEARS AGO. IN 2023 PATIENT STARTED TO EXPERIENCE PAIN AND SWELLING, PATIENT HAD X-RAY DONE AND THE PHYSICIAN CONFIRMED THAT THE PATIENT WOULD NEED KNEE REPLACEMENT AGAIN DUE TO A RECALL ON THE PRODUCT. PATIENT HAD REVISION SURGERY ON (B)(6) 2023.

  Patient problems: Cyst(s); Osteolysis; Pain; Swelling/ Edema

  MAUDE report 18531240 ↗
• InjuryOct 17, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2014. APPROXIMATELY 4 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2018. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17949804 ↗
• InjuryDec 1, 2022Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  AS REPORTED BY LEGAL BRIEF, ON (B)(6) 2017, PATIENT UNDERWENT A LEFT KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK DEVICE. IN (B)(6) 2019, A BONE SCAN REVEALED STRESS SHIELDING AND POSTERIOR AND SUPERIOR FEMORAL EFFUSION. PATIENT WAS DIAGNOSED WITH CONTINUED PAIN IN LEFT KNEE AND CONTINUED EFFUSION OF LEFT KNEE. THUS, DUE TO WORSENING PAIN, EFFUSION, CHRONIC SYNOVITIS, SWELLING, LOSS OF RANGE OF MOTION, LEFT FOOT DROP, AND FINDINGS OF ¿RADIOGRAPHS AND PHYSICAL EXAM OF LEFT TOTAL KNEE ARTHROSCOPY ARE CONSISTENT WITH POLYETHELENE WEAR¿, PATIENT IS SCHEDULED FOR A LEFT KNEE REPLACEMENT REVISION SURGERY IN (B)(6) 2023 TO REMOVE THE DEFECTIVE OPTETRAK DEVICE. UPON INFORMATION AND BELIEF, THE EFFUSIONS, SYNOVITIS, SWELLING, PAIN, AND LIMITED RANGE OF MOTION ARE DUE TO POLYETHELENE WEAR.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Joint effusion; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15900797 ↗

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