Optetrak Logic 02-012-41-2525Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862003140), received between Jun 20, 2024 and Mar 18, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 reports).

2 other recalls 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REPORT 2 OF 2 FOR THIS EVENT. AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THREE (3) YEARS, TEN (10) MONTHS LATER, THE PATIENT UNDERWENT A RIGHT KNEE REVISION OF THE TIBIAL COMPONENTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES OF THE EXPLANTS WERE PROVIDED AND PRE-OPERATIVE RADIOGRAPHS WERE PROVIDED. NO ADDITIONAL CLINICAL INFORMATION WAS PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 24629508 ↗
• InjuryApr 3, 2025Loosening 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 LEFT TOTAL KNEE ARTHROPLASTY, AND THEN APPROXIMATELY 5 YEARS AND 5 MONTHS LATER WAS REVISED DUE TO A FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC PATELLAR AND FEMORAL LOOSENING. THE PATIENT WAS REVISED TO COMPETITORS DEVICES. A COMPLETE SYNOVECTOMY WAS PERFORMED. THE POLYETHYLENE WAS REMOVED, THERE WAS MINIMAL WEAR. THE PATELLA COMPONENT WAS GROSSLY LOOSE, AND IT APPEARED THERE WAS AN OLD PATELLA FRACTURE WITH LARGE INFERIOR FRAGMENT FIBROUSLY UNITED. THE FEMORAL COMPONENT WAS GROSSLY LOOSE, THERE WAS MODERATE BONE RESORPTION AND NECROSIS IN THE MEDIAL FEMORAL CONDYLE. THE TIBIAL WAS LOOSELY AFFIXED AND REMOVED WITHOUT DIFFICULTY. STERILE DRESSINGS WERE APPLIED, AND THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM. NO COMPLICATIONS. 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: Bone Fracture(s); Necrosis; Synovitis

  MAUDE report 21763548 ↗
• InjuryAug 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 90 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20108452 ↗
• InjuryJun 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 45 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DISCOMFORT, LIMITED ACTIVITIES OF DAILY LIVING, IMPACTED QUALITY OF LIFE; DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE; FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Emotional Changes; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19575622 ↗

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-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inser
• 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