Optetrak Logic 02-012-35-2515Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862001795), received between Apr 27, 2021 and Jan 22, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2025Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA PATIENT ID: (B)(6). ON (B)(6) 2024, (B)(6), RN- ADDITIONAL INFORMATION FROM LEGAL 6 FEB 2024. REVISION OPERATIVE REPORT OF (B)(6) 2021- OPERATION: REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY OF FEMORAL COMPONENT AND TIBIAL POLYETHYLENE EXCHANGE. POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE WITH LOOSE FEMORAL COMPONENT AND SEVERE OSTEOLYSIS. OPERATIVE FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH A COPIOUS AMOUNT OF CLEAR SYNOVIAL FLUID AND AN ABUNDANCE OF EXTRANEOUS SYNOVIAL TISSUE. A COMPLETE SYNOVECTOMY WAS THEN PERFORMED. THERE WAS A GROSSLY LOOSE FEMORAL COMPONENT WITH MODERATE OSTEOLYSIS OF THE MEDIAL FEMORAL CONDYLE, REQUIRING AUGMENTATION ON THE REVISION COMPONENT. THERE WAS A WELL-FIXED TIBIAL COMPONENT, AS WELL AS PATELLAR COMPONENT. "THERE WAS A MODERATE AMOUNT OF OSTEOLYSIS OF THE POLYETHYLENE COMPONENT." THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. PRODUCT: OPTETRAK LOGIC FEMORAL COMPONENT (02-010-01-0325, SN (B)(6). CONCOMITANTS TIBIA TRAY (02-012-45-2525, SN (B)(6) / TIBIAL INSERT (02-012-35-2515, SN (B)(6) / STEM EXTN FLUTED KNEE (204-34-02, (B)(6) / EXTENSION SCREW STEM TIBIAL (204-70-

  Patient problems: Failure of Implant; Implant Pain; Osteolysis; Synovitis

  MAUDE report 21211326 ↗
• InjuryMay 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A FEMORAL FRACTURE ADJACENT TO THE TOTAL KNEE FEMORAL IMPLANT. THE POSTERIOR STABILIZED INSERT WAS WORN MORE THAN EXPECTED AND LEFT FEMORAL COMPONENT WAS FOUND TO BE LOOSE. THE PATELLA COMPONENT WAS ALSO LOOSE. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT AND FEMORAL FRACTURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Cyst(s); Insufficient Information

  MAUDE report 19391440 ↗
• InjuryNov 16, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 7 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2021. 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) 2021. DIAGNOSIS: FAILED RIGHT TOTAL KNEE WITH LOOSE FEMORAL COMPONENT AND SEVERE OSTEOLYSIS FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH A COPIOUS AMOUNT OF CLEAR SYNOVIAL FLUID AND AN ABUNDANCE OF EXTRANEOUS SYNOVIAL TISSUE. A COMPLETE SYNOVECTOMY WAS THEN PERFORMED. THERE WAS A GROSSLY LOOSE FEMORAL COMPONENT WITH MODERATE OSTEOLYSIS OF THE MEDIAL FEMORAL CONDYLE, REQUIRING AUGMENTATION ON THE REVISION COMPONENT. THERE WAS A WELL-FIXED TIBIAL COMPONENT AS WELL AS PATELLAR COMPONENT. THE POLYETHYLENE INSERT WAS REMOVED AND THERE WAS A MODERATE AMOUNT OF OSTEOLYSIS OF THE POLYETHYLENE COMPONENT. THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 18146999 ↗
• InjuryAug 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  OPERATIVE REPORT - REVISION OF RIGHT TOTAL KNEE POLYETHYLENE AND FEMORAL COMPONENT. FAILED RIGHT TOTAL KNEE POLYETHYLENE AND FEMORAL COMPONENT DUE TO PREMATURE POLYETHYLENE WEAR AND OSTEOLYSIS OF THE FEMORAL COMPONENT. EARLY ASEPTIC FAILURE AND LOOSENING. THERE WAS FOUND TO BE ENCAPSULATED POLYETHYLENE DEBRIS THROUGHOUT THE ENTIRE SYNOVIUM. THERE WAS SEVERE WEAR OF THE POLYETHYLENE COMPONENT WITH PITTING AND FRACTURING OF THE POLYETHYLENE ITSELF. THE TIBIAL COMPONENT WAS FOUND TO BE WELL FIXED TO THE BONE WITH NO EVIDENCE OF SURROUNDING OSTEOLYSIS. THE PATELLA COMPONENT WAS ALSO FOUND TO BE WELL FIXED. THERE WAS FOUND TO BE A LARGE OSTEOLYTIC DEFECT OF THE LATERAL FEMORAL CONDYLE, MEASURING ABOUT 5ML IN DIMENSION, IT WAS FILLED WITH BONE GRAFT. INFECTION WORK UP WAS NEGATIVE. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Foreign Body Reaction; Inadequate Osseointegration; Insufficient Information; Osteolysis; Synovitis

  MAUDE report 17607343 ↗
• InjuryFeb 14, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT SIDE TKA, THE 65 Y/O FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD MAJOR LYSIS. PATELLA SOWED SIGNIFICANT WEAR AND TIBIAL INSERT WAS WORN. SURGEON USED COMPETITORS IMPLANTS FOR REVISION. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 16372760 ↗
• MalfunctionApr 27, 2021Crack; Crack

  AS REPORTED, DURING THE INITIAL IMPLANT FOR THIS (B)(6) YEAR OLD FEMALE PATIENT, THE POLYETHYLENE TIBIAL INSERT SIZE1, 9MM TWO (2) PIECES WERE CRACKED WHEN THE SURGEON WAS INSERTING THE TIBIAL INSERT DRIVER (BEFORE IMPACTION). THE CRACK WAS FOUND DAMAGED IN THE AREA IN CENTRAL MUSHROOM HOLE, PERIPHERAL RIM AND BACKSIDE OF ARTICULAR SURFACE. THE OPERATION TIME DELAYED ABOUT ONE HOUR. THE DEVICES WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11733796 ↗

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-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