Optetrak Logic 02-012-44-3515Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862173621), received between Feb 1, 2022 and Oct 2, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Naturally Worn” (10 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA LETTER OF PRESERVATION CASE- (B)(4) RK IS ASSOCIATED WITH THIS CASE. NOTICE OF PRESERVE PATHOLOGY AND EXPLANT MATERIALS. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20354245 ↗
• InjuryAug 15, 2024Unstable; Naturally Worn; Lack of Effect; Unstable; Naturally Worn; Lack of Effect

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS, LIMITED RANGE OF MOTION, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, INSTABILITY, POLYETHYLENE WEAR, OSTEOLYSIS, CASE COMPLEXITY MODIFIER. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19995815 ↗
• InjuryJul 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 113 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DISCOMFORT AND SWELLING. 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: Pain; Swelling/ Edema; Synovitis

  MAUDE report 19730173 ↗
• InjuryJul 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 113 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DISCOMFORT AND SWELLING. 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: Discomfort; Failure of Implant; Joint effusion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19729789 ↗
• InjuryJun 5, 2024Mechanical Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 39 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR PAIN, SWELLING, STIFFNESS, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, TISSUE DAMAGE, REVISION SURGERY, DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT LOOSENING, AND BONE LOSS. 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; Failure of Implant; Implant Pain; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 19469979 ↗
• InjuryJun 5, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 44 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19466625 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PATELLAR COMPONENT LOOSENING, POLYETHYLENE PITTING, OSTEOLYSIS, BONE LOSS, PAIN AND SWELLING. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19371401 ↗
• InjuryAug 10, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2018. APPROXIMATELY 4 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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) 2022. DIAGNOSIS: FAILED RIGHT KNEE REPLACEMENT SECONDARY TO WEAR OF THE BEARING SURFACE FINDINGS: FOUND EXUBERANT FOREIGN BODY REACTION, A GROSS CONTAMINATION OF THE SYNOVIUM WITH POLYETHYLENE DEBRIS, AND VERY SIGNIFICANT WEAR OF THE POLYETHYLENE INSERT WITH TREMENDOUS LOSS OF SUBSTANCE FROM THE MEDIAL ASPECT OF THE IMPLANT. THE OTHER IMPLANTS WERE WELL FIXED AND IN GOOD CONDITION. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Discomfort; Failure of Implant; Joint Laxity; Joint effusion

  MAUDE report 17500162 ↗
• InjuryJun 12, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2014. THE PATIENT WAS FURTHER ADVISED BY HER TREATING PHYSICIAN THAT SHE WILL LIKELY REQUIRE TOTAL KNEE REVISION SURGERY TO HER LEFT KNEE DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE TIBIAL INSERT. 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: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Osteolysis

  MAUDE report 17105355 ↗
• InjuryJun 12, 2023Mechanical Problem; Unstable; Detachment of Device or Device Component; Naturally Worn; Mechanical Problem; Unstable; Detachment of Device or Device Component; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022 DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE TIBIAL INSERT. 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: Discomfort; Failure of Implant; Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17105068 ↗
• InjuryFeb 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS AND 7 MONTHS POST RIGHT SIDE TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13418870 ↗