Optetrak Logic 02-012-51-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862230447), received between Aug 31, 2022 and Nov 12, 2023 — classified as 8 injuries.

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

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FOUR YEARS POST RIGHT TKA, THE 79 Y/O MALE PATIENT HAD A REVISION DUE TO POLY WEAR. PATIENT WAS REVISED INTO A LOGIC PS. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18117454 ↗
• InjuryNov 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST OP INITIAL LEFT TKA, THIS 78 Y/O FEMALE PATIENT WAS REVISED DUE POLY WEAR. EVERYTHING WAS REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING: DISPOSED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18083428 ↗
• InjurySep 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2023 AND THE FEMORAL COMPONENT AND TIBIAL INSERT WERE REMOVED DUE TO WEAR AS WELL AS FEMORAL LOOSENING. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Aseptic loosening; Failure of Implant; Insufficient Information

  MAUDE report 17706337 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5 MONTHS POST OP THE INITIAL LEFT TKA, THIS 76 Y/O MALE PATIENT WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED. DEVICES ARE NOT RETURNING, DISPOSED OF BY HOSPITAL.

  Patient problems: Bacterial Infection

  MAUDE report 16333792 ↗
• InjuryDec 6, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL LEFT SIDE TKA, THE FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS & PHOTOS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL DISPOSED THE DEVICE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15928223 ↗
• InjuryOct 10, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO POLY WEAR. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15569382 ↗
• InjurySep 14, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON 10/17/2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS 9 MONTHS POST THE INITIAL PROCEDURE DUE TO INSTABILITY. THE PATIENT WAS LAST KNOWN TO BE STABLE FOLLOWING THE EVENT.

  Patient problems: Joint Laxity

  MAUDE report 15421956 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 73 YO FEMALE PATIENT, WEIGHT 91.15 KG, THAT HAD AN INITIAL LEFT KNEE PROCEDURE ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE DUE TO A STIFF KNEE APPROXIMATELY 1 YEAR 4 MONTHS POST THE INITIAL IMPLANT DATE. THEY WERE REVISED TO EXACTECH DEVICES. NO EXPLANT WILL BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

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

  MAUDE report 15331635 ↗