Optetrak Logic 02-012-41-1020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862003096), received between Oct 23, 2024 and Oct 23, 2024 — classified as 1 injury.

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

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.

• InjuryOct 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - LINDA TEPPER 10/11/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 10/9/24. ATTACHED EMAIL, INITIAL OP REPORT/PRODUCT ID, AND REVISION OP REPORT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PRE-OP AND POST-OP DIAGNOSES: 1. SEVERE LEFT KNEE/TIBIA BONE LOSS. 2. SEVERE LEFT KNEE/FEMUR BONE LOSS. 3. ASEPTIC LOOSENING OF LEFT TKA. 4. FLEXION CONTRACTURE LEFT KNEE. 4. PATELLAR DISLOCATION LEFT. INDICATIONS: PATIENT IS A 80 Y.O. FEMALE WITH A HISTORY OF PROGRESSIVELY WORSENING OF PAIN AND DISABILITY. SPECIFICS: SEVERE LEFT KNEE/TIBIA AND FEMUR BONE LOSS, ASEPTIC LOOSENING OF LEFT TOTAL KNEE ARTHROPLASTY, FLEXION CONTRACTURE LEFT KNEE, PATELLAR DISLOCATION LEFT. NEGATIVE FOR INFECTION. INCORPORATING THE PREVIOUS SCAR¿ POLYETHYLENE COMPONENT WAS REMOVED. USING A COMBINATION OF MICROSAGITTAL SAW AND FLEXIBLE OSTEOTOME, THE COMPONENTS WERE REMOVED WITH MINIMAL BONE LOSS. ANY RESIDUAL CEMENT MANTLE WAS THEN METICULOUSLY REMOVED, ALONG WITH ANY NON-VIABLE BONE OR SOFT TISSUE. GIVEN THE SEVERE BONE LOSS THAT WAS ENCOUNTERED ON THE TIBIA AND FEMUR A PERMANENT RECON WAS THEN SHAPED AND IMPLANTED INTO THE TIBIA. REVISION LEFT TKA, LENGTHENING OF MULTIPLE HAMSTRING TENDONS. THE PAT

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Osteolysis; Pain; Synovitis

  MAUDE report 20513392 ↗