Optetrak Logic 02-012-39-3020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862002662), received between Nov 7, 2023 and Nov 7, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K932776); 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.

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.

• InjuryNov 7, 2023Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2010. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 12 YEARS 7 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT STATES THAT THE KNEE WAS GROSSLY UNSTABLE IN ALL PLANES THROUGH THE RANGE OF MOTION. THE SYNOVIUM WAS BLACK FROM METAL DEBRIS. THE FEMORAL COMPONENT WAS WELL FIXED AND ALIGNED/SIZED APPROPRIATELY. THE TIBIAL IMPLANT WAS LOOSE. THE RIGHT TIBIAL COMPONENT WAS SHIFTED INTO EXCESSIVE POSTERIOR SLOPE TO MOTION OF THE IMPLANT AND OSTEOLYSIS AT THE FIXATION INTERFACE. THE PATELLAR IMPLANT WAS INTACT WITHOUT SIGNIFICANT WEAR, AND REMAINED WELL FIXED. THE MCL WAS ABSENT. 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.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18083748 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932776. One submission often covers many models, so check the product and lot details in each record.

• Z-0927-06 · Dec 19, 2005 · Terminated
  Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONL
• Z-1379-05 · Jun 2, 2005 · Terminated
  The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SING