Optetrak Logic 02-012-44-5015Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862173744), received between Dec 4, 2020 and Jul 1, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 43 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEARJOINT PAIN, SWELLING AND STIFFNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19649267 ↗
• InjuryApr 12, 2024Naturally Worn; 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 AND 2 MONTHS AFTER INITIAL IMPLANT. OPERATIVE REPORT POSTOPERATIVE DIAGNOSIS; DEBRIS SYNOVITIS, SCAR TISSUE. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Scar Tissue; Synovitis

  MAUDE report 19094384 ↗
• InjuryJun 26, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2021. APPROXIMATELY 11 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND LEFT KNEE REVISION ON (B)(6) 2022 DUE TO PAIN, SWELLING, LOSS OF MOTION, SYNOVIAL SCARRING, SYNOVITIS, PREMATURE COMPONENT WEAR, INSTABILITY, FORMATION OF CYSTS; NEED FOR LEFT KNEE ASPIRATION PROCEDURES TO RELIEVE EXCESS ACCUMULATED SYNOVIAL FLUID. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Insufficient Information; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 17200946 ↗
• InjuryJun 16, 2023Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2014. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 9 YEARS AFTER THEIR INITIAL PROCEDURE. PREOPERATIVE X-RAYS SHOWED INCREASING LUCENCY ALONG THE ANTERIOR PORTION OF THE RIGHT FEMORAL PROSTHESIS, SUGGESTING LOOSENING, AS WELL AS SEVERE PROFOUND OSTEOLYSIS AND RADIOLUCENCIES AROUND BOTH COMPONENTS. INTRA-OPERATIVE FINDINGS REPORTED INCLUDE EXTENSIVE WEAR POSTERIORLY ON THE FEMUR AND SOME UNDERSURFACE WEAR. IT WAS NOTED THAT THE TIBIAL POLYETHYLENE COMPONENT WAS NOT ENGAGED IN THE LOCKING MECHANISM AND THE METAL CAP COVERING THE TIBIAL TRAY HOLES HAD BECOME LOOSE. EXTENSIVE SYNOVITIS AND EXTENSIVE OSTEOLYSIS WERE ALSO REPORTED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO ADDITIONAL INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 17143902 ↗
• InjuryJun 7, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A FIRST LEFT KNEE ARTHROPLASTY REVISION ON (B)(6) 2017 AND THEN APPROXIMATELY 5 YEARS LATER WAS REVISED FOR A SECOND TIME ON (B)(6) 2023 FOR OSTEOLYSIS, BONE LOSS, SYNOVITIS COMPONENT LOOSENING, POLYWEAR AND DEBONDING, INSTABILITY, JOINT PAIN, STIFFNESS, AND SWELLING, FOREIGN BODY REACTION SYNOVITIS: INSUFFICIENT INFORMATION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 17080679 ↗
• InjurySep 9, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL TOLLING AGREEMENT, THAT A MALE PATIENT WHO WAS INITIALLY IMPLANTED ON THEIR LEFT KNEE ON (B)(6) 2012, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 9 YEARS 7 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR REASONS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15392162 ↗
• InjuryApr 18, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2014. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2020, APPROXIMATELY 6 YEARS 6 MONTHS AFTER THEIR PRIMARY SURGERY. (B)(6) 2020 OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC LOOSENING; POLYETHYLENE DISASSOCIATION. THE SURGEON NOTED THE POLYETHYLENE HAD DISASSOCIATED FROM THE TIBIAL BASEPLATE AND REMOVED MANUALLY. THE FEMORAL COMPONENT WAS LOOSELY AFFIXED AND REMOVED, LEAVING RESIDUAL CEMENT AND LARGE CAVITARY DEFECTS IN THE METAPHYSIS OF THE DISTAL FEMUR. THE TIBIAL COMPONENT WAS SOLIDLY AFFIXED AND REMOVED, EXTRACTING ALL CEMENT. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM. 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: Failure of Implant

  MAUDE report 11683319 ↗
• InjuryDec 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2015. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946472 ↗
• InjuryDec 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2015. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946462 ↗