Optetrak Logic 02-012-47-1009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862174130), received between Sep 8, 2022 and Jul 25, 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 (K111400); 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.

• InjuryJul 25, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE FEMALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 7 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023 DIAGNOSIS: RIGHT KNEE POLYETHYLENE WEAR, OSTEOLYSIS WITH FEMORAL COMPONENT LOOSENING THE PATIENT HAD EXTENSIVE SYNOVITIS WITH SMALL FRAGMENTS OF POLYETHYLENE WITHIN THE KNEE. A THOROUGH SYNOVECTOMY WAS PERFORMED. COMPONENTS WERE EVALUATED AND COULD SEE THERE WAS EXTENSIVE OXIDATION AND POLYETHYLENE WEAR ON THE TIBIAL POLYETHYLENE. THERE WAS ALSO EVIDENCE OF OSTEOLYSIS OVER THE MEDIAL TIBIA. EVALUATION OF THE PATELLAR COMPONENT REVEALED EXTENSIVE WEAR OF THE PATELLAR COMPONENT AS WELL. WITH THE FEMORAL COMPONENT THERE WAS EXTENSIVE OSTEOLYSIS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17387888 ↗
• InjuryFeb 27, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 7 YEARS 3 MONTHS POST THE INITIAL PROCEDURE DUE TO PAIN. THE BONE SCAN AND MRI DID NOT SHOW MUCH PER THE SURGEON¿S PA. POLY EXCHANGED. SOME WEAR AND POSSIBLE OXIDATION WERE NOTED ON THE MEDIAL SIDE OF THE INSERT. A MORE CONSTRAINED 9 CRC WAS IMPLANTED. THERE WERE NO COMPLICATIONS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. EXPLANTS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 16448797 ↗
• InjurySep 8, 2022Fracture; Unstable; Naturally Worn; Insufficient Device Problem Information; Fracture; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL LEFT TKA, THIS 77 Y/O FEMALE PATIENT HAD A POLY EXCHANGE, OLD IMPLANT REMOVED, NEW IMPLANT IMPLANTED. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING, HOSPITAL WOULD NOT RELEASE IMPLANT.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Erosion; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15381005 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. 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