Optetrak Logic 02-012-44-6011Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862173843), received between May 9, 2023 and Aug 13, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 reports).

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

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 120 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Synovitis

  MAUDE report 19975815 ↗
• InjuryJul 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 71 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS, NEGATIVELY AFFECTED MOBILITY AND QUALITY OF LIFE, REVISION SURGERY; PAIN FOLLOWING SURGERY AND DURING THE REHABILITATION PERIOD, PHYSICAL THERAPY; LIMITED ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 19793286 ↗
• InjuryApr 1, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Inflammation; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 19010049 ↗
• InjuryMar 28, 2024Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 AND THEN APPROXIMATELY 8 YEARS LATER ON (B)(6) 2023 EXPERIENCED A SURGICAL REVISION. REVISION OPERATIVE REPORT OF (B)(6) 2023 -POSTOPERATIVE DIAGNOSIS- FAILED RIGHT TOTAL KNEE/REVISION RIGHT TOTAL KNEE (TIBIAL, FEMORAL AND POLYETHYLENE COMPONENTS). PATIENT WAS REVISED TO COMPETITOR'S DEVICES. FINDINGS: LOOSE FEMORAL IMPLANT- REMOVED EASILY WITH MODERATE BONE LOSS. EXCESSIVE WEAR OF POLYETHYLENE WITH SIGNS OF OXIDATION/YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY. DISTAL FEMORAL BONE LOSS WAS MODERATE. THE TIBIAL BONE LOSS WAS EXTENSIVE AND REPAIRED WITH TIBIAL CONE. PATELLA BUTTON WAS STABLE AND NOT REVISED. PATIENT WAS TAKEN TO PACU IN STABLE CONDITION. THERE IS NO OTHER PATIENT OR MEDICAL INFORMATION PROVIDED. NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain; Synovitis

  MAUDE report 18990478 ↗
• InjuryMay 9, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 8 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. 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. REVISION OP REPORT: 8 MAY 2023/(B)(4) RECEIVED VIA LEGAL 13 APR 2023. DIAGNOSIS: FAILED LEFT KNEE REPLACEMENT. FINDINGS: THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE KNEE JOINT CONSISTENT WITH A SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUES. THIS WAS TINY, SMALL BALLS OF LIGHT BROWN SYNOVIUM ALONG WITH A "PSEUDO-CAPSULE" OF DENSE SOFT TISSUE RIND. THE SURGEON RESECTED AS MUCH OF THIS AS SAFELY POSSIBLE. THE TOTAL AMOUNT OF SOFT TISSUE DAMAGE THAT REQUIRED RESECTION WAS ABOUT 20 OZ. THE SURGEON EXAMINED THE POLYETHYLENE - EXCESSIVE WEAR WAS PRESENT WITH SIGNS OF OXIDATION/ YELLOW DISCOLORATION, PITTING, CRACKING, AND DELAMINATION OF THE POLY. DISTAL FEMORAL BONE LOSS WAS SEVERE BUT DID NOT REQUIRE A FEMORAL CONE. EXTENSIVE MEDIAL FEMORAL BONE LOSS WITH "GOLF BALL" SIZE BONE LOSS - REQUIRED 2 SCREWS AS REBAR AUGMENTATI

  Patient problems: Synovitis

  MAUDE report 16893912 ↗