Optetrak 230-03-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862061737), received between Feb 14, 2020 and Nov 26, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2011 AND THEN APPROXIMATELY 12 YEARS, 11 MONTHS LATER ON (B)(6) 2024 THE PATIENT HAD A SURGICAL REVISION. REVISION OPERATIVE REPORT (B)(6) 2024-POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING OF RIGHT TOTAL KNEE. PATIENT REVISED TO COMPETITOR'S DEVICES. PATIENT WITH RADIOGRAPHIC EVIDENCE OF ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS WITH AREAS OF OSTEOLYSIS IN FEMUR AND TIBIA. NEGATIVE FOR INFECTION. THERE IS EVIDENCE OF CATASTROPHIC POLYETHYLENE WEAR WITH VISUAL DETERIORATION OF THE POLYETHYLENE WITH MULTIPLE POLYETHYLENE FRAGMENTS THROUGHOUT THE KNEE. PATELLA POLYETHYLENE COMPONENT WAS UNDERMINED WITH AREAS OF OSTEOLYSIS. THE PATIENT HAS EXPERIENCED IMPLANT PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS AWAKENED AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION PROVIDED.

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 20788279 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A OPTETRAK AYSMETRIC FEMOR (RIGHT SIZE 1) (CATALOG 230-03-01, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZES 1F/1T 2F/1T (CATALOG 200-04-21, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 1 - 18MM (CATALOG 200-21-18, SERIAL (B)(4)) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2014, APPROXIMATELY 44 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING TIBIA; INSTABILITY; PAIN. THE EXACTECH WERE REMOVED AND REPLACED WITH PFC« SIGMA TC3 FEMORAL RIGHT SIZE 2, MBT REVISION TIBIAL TRAY CEMENTED SIZE 2 AND TC3 RP TIBIAL INSERT SIZE 2 10MM.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9714397 ↗