Optetrak Logic 02-012-47-2509Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10885862159144), received between Nov 10, 2021 and Jan 15, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Naturally Worn” (17 reports).

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

1 other recall cover devices cleared under the same FDA submission (K111400); 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Naturally Worn

  IT WAS REPORTED THAT A PATIENT, INITIAL LEFT KNEE IMPLANTED AND THEN UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 8 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO SYNOVITIS AND SWELLING TO A NEW SIZE 9 INSERT. THERE WERE NO ISSUES WITH SURGERY. THE EXPLANTS ARE NOT AVAILABLE FOR RETURN. X-RAYS AND DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Swelling/ Edema; Synovitis

  MAUDE report 24079684 ↗
• InjurySep 3, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND EXTENSIVE OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Failure of Implant; Joint effusion; Osteolysis; Synovitis

  MAUDE report 20124663 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT 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 20031028 ↗
• InjuryJun 4, 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 57 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: Implant Pain; Insufficient Information; Swelling/ Edema

  MAUDE report 19462013 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 8 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO SYNOVITIS AND SWELLING TO A NEW SIZE 9 INSERT. THERE WERE NO ISSUES WITH SURGERY. THE EXPLANTS ARE NOT AVAILABLE FOR RETURN. X-RAYS AND DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Swelling/ Edema; Synovitis

  MAUDE report 18927461 ↗
• InjuryNov 27, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2016. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR. 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.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18213613 ↗
• InjuryJul 20, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2016. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR. 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: Failure of Implant; Insufficient Information

  MAUDE report 17358302 ↗
• InjuryJun 21, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THE 71 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR. EVERYTHING WAS REMOVED AND REVISED INTO A COMPETITOR'S DEVICES. THERE WAS NO BREAKAGE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED AT THE HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17171495 ↗
• InjuryMay 8, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 60 Y/O FEMALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2020. APPROXIMATELY 2 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO SWELLING. REVISION OP REPORT: 8 MAY 2023/ (B)(4) RECEIVED VIA LEGAL 11 APR 2023. WITH THE REPORTS OF CONTINUED FUSION WITHOUT AN EXPLANATION AND NEGATIVE, ESR, CRP AS WELL AS CT SCAN SHOWING NO SIGNIFICANT OSTEOLYSIS OR FRANK LOOSENING. THE NEED FOR A LEFT KNEE REVISION WAS EXPRESSED. DURING THE SURGERY THE PATIENT HAD A LARGE EFFUSION WITHOUT PURULENCE OR METALOSIS PRESENT. A SYNOVECTOMY WAS PERFORMED. THERE WAS BEGINNING OF PITTING ABOUT THE MEDIAL COMPARTMENT AND DISCOLORATION ASSOCIATED WITH THE POLYETHYLENE. THE PATIENT WAS AWOKEN AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS OCCURRED THROUGHOUT THE CASE.

  Patient problems: Failure of Implant; Joint effusion; Synovitis

  MAUDE report 16888510 ↗
• InjuryMay 3, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2018. SHE HAD LEFT KNEE REVISION (B)(6) 2023, APPROXIMATELY 5 YEARS AFTER THEIR INITIAL PROCEDURE. POSTOPERATIVE DIAGNOSIS: LEFT TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE FAILURE. SURGEON NOTED THAT IT WAS IMMEDIATELY APPARENT THERE WAS A LARGE EFFUSION, WHICH WAS NONPURULENT AND NO METALOSIS PRESENT. THE SYNOVIUM WAS HYPERTROPHIC WITH BROWNISH DISCOLORATION AS WELL. THERE WAS NO DESTRUCTION OF THE POSTERIOR TIBIAL LIP OF THE TIBIAL TRAY AND OTHERWISE WAS DEEMED COMPETENT. THE POLYETHYLENE SHOWED PITTING, DELAMINATION AND DESTRUCTION OF THE LATERAL COMPARTMENT. PATELLAR POLYETHYLENE APPEARED PRISTINE, AND WAS LEFT IN. 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; Implant Pain; Joint effusion; Synovitis

  MAUDE report 16860940 ↗
• InjuryApr 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST INITIAL BILATERAL TKA, THE 56 Y/O FEMALE PATIENT HAD A REVISION FOR HER LEFT KNEE DUE TO POLY WEAR AND INSERT CHANGE. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THE DEVICES WERE DISPOSED BY HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16739272 ↗
• InjuryMar 6, 2023Naturally Worn; Naturally Worn

  THE REVISION REPORTED WAS LIKELY THE RESULT OF WEAR OF THE TIBIAL INSERT. CONTRIBUTING FACTORS TO THE WEAR AND DELAMINATION MAY HAVE BEEN IMPLANT POSITIONING AND BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS.

  Patient problems: Insufficient Information; Synovitis

  MAUDE report 16492598 ↗
• InjuryJan 5, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST INITIAL BILATERAL TKA, THE 56 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR AND INSERTS CHANGE AND PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THE DEVICES WERE DISPOSED BY HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16109366 ↗
• InjuryDec 21, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST OP THE INITIAL RIGHT TKA, THIS 84 Y/O FEMALE PATIENT WAS REVISED DUE TO INSTABILITY. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WERE NO REPORTED ISSUES DURING THE REVISION PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION//MEDICAL HISTORY REPORTED. DEVICES WILL NOT BE RETUNING; DISPOSED OF BY HOSPITAL. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16028887 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2017, WAS REVISED ON OR ABOUT (B)(6) 2022, APPROXIMATELY 4 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE MD REQUESTED POLY SWAP DUE TO RECALL. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT RETURNING AS THE HOSPITAL REFUSED TO RETURN.

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

  MAUDE report 15574387 ↗
• InjurySep 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL TKA, THIS 69 Y/O FEMALE PATIENT WAS REVISED DUE IS SCHEDULED TO UNDER GO A REVISION OF A TOTAL KNEE ARTHROPLASTY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15409950 ↗
• InjuryJun 7, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL RIGHT TKA, THE FEMALE PATIENT HAD A REVISION DUE TO EFFECTED POLY CAUSED EXCESSIVE WEAR WHICH HAS LED TO LYSIS AND PAIN. PATIENT WAS REVISED TO A 11MM INSERT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14623184 ↗
• InjuryApr 26, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY THREE YEARS POST INITIAL TKA, THIS (B)(6) MALE PATIENT UNDERWENT A REVISION FOR AN UNKNOW REASON. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14210525 ↗
• InjuryMar 17, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY EIGHT MONTHS POST INITIAL RIGHT TKA, THIS (B)(6) FEMALE PATIENT HAD A REVISION DUE TO PROSTHESIS WEAR, PLUS ARTHROFIBROSIS. THERE WAS NO BREAKAGE TO THE DEVICE AND NO SURGICAL DELAY/PROLONGATION. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 13796010 ↗
• InjuryFeb 19, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL RIGHT SIDE TKA, THIS (B)(6) Y/O FEMALE PATIENT HAD A REVISION DUE TO INCREASE WEAR OF THE POLYETHYLENE INSERT. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13565358 ↗
• InjuryNov 10, 2021Naturally Worn; Naturally Worn

  AS REPORTED, THIS FEMALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POLY WEAR. THE POLY IS GREATER THAN 5 YEARS OLD AT THE TIME OF IMPLANTATION. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12787949 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013