Optetrak Logic 02-012-48-4009Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10885862174482), received between Jul 19, 2021 and Jan 7, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Naturally Worn” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 85 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, AMBULATION DIFFICULTIES, FIBROSIS, JOINT EFFUSION, JOINT LAXITY, PAIN, AND SWELLING/EDEMA. INITIAL 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21096442 ↗
• InjuryOct 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 66 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2018, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2023, APPROXIMATELY 5 YEARS 1 MONTH POST THE INITIAL PROCEDURE. REVISION OF RECALLED DEVICES INDICATED. ALL DEVICES WERE REMOVED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAY OR IMAGING WAS AVAILABLE. THE PRODUCT IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED AT THE HOSPITAL. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20482329 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2018, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 6 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. IT WAS A COMPLETE REVISION TO A COMPETITOR¿S DEVICES. SIGNIFICANT WEAR AND OSTEOLYSIS WAS REPORTED. NO ISSUES WITH THE SURGERY WERE REPORTED. NO EXPLANTS ARE AVAILABLE FOR ANALYSIS. NO FURTHER INFORMATION.

  Patient problems: Osteolysis

  MAUDE report 20008793 ↗
• InjuryApr 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTS THAT A PATIENT IS HAVING RIGHT KNEE PAIN AND SWELLING. THE 67-YEAR-OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2024, APPROXIMATELY 5 YEARS, 3 MONTHS AFTER IMPLANT; THE INSERT AND PATELLA WERE EXCHANGED DUE TO WEAR/PITTING. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. PHOTOS WERE PROVIDED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - DISPOSED AT THE HOSPITAL. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 19039607 ↗
• InjuryMar 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 74 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 7 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY WEAR. EVERYTHING WAS REMOVED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGE DURING THE EVENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE REP WAS UNABLE TO OBTAIN ANY PHOTOS OF THE EXPLANTS OR X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18984177 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTS THAT A PATIENT IS HAVING RIGHT KNEE PAIN AND SWELLING. THE PATIENT HAD BILATERAL KNEE REPLACEMENTS ON (B)(6) 2018 AND WAS SCHEDULED FOR SURGICAL REVISION IN (B)(6) 2024. AS OF (B)(6) 2024, THERE HAS BEEN NO NOTIFICATION OF SURGICAL REVISION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE ARE NO IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 18981840 ↗
• InjuryNov 7, 2023Fracture; Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR. REVISED FROM CR TO PS. THE FEMORAL COMPONENT AND LINER WERE EXCHANGED. 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 18086375 ↗
• InjurySep 25, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 1 MONTH AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, POLYETHYLENE WEAR AND OSTEOLYSIS. 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. REVISION OP REPORT ON (B)(6) 2023: DIAGNOSIS: RIGHT TOTAL KNEE WITH POLYETHYLENE FAILURE AND RESULTANT OSTEOLYSIS THERE WAS A LARGE EFFUSION WHICH WAS NONPURULENT. NO METALOSIS PRESENT. HE HAD A HYPERPROLIFERATIVE SYNOVIUM WHICH WAS BROWNISH DISCOLORATION. THEY WERE ABLE TO REMOVE THE POLYETHYLENE AND WAS CERTAINLY A FRACTURE, PITTING AND DELAMINATION OF THE POLYETHYLENE ON BOTH THE MEDIAL AND LATERAL COMPARTMENTS. THERE WAS SOME OSTEOLYSIS ABOUT THE POSTERIOR MEDIAL FEMORAL CONDYLES BUT WAS NOT EXTENSIVE. THE TIBIA HAD A LARGE LYTIC LESION ABO

  Patient problems: Implant Pain; Joint effusion; Osteolysis; Swelling/ Edema

  MAUDE report 17807706 ↗
• InjurySep 4, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2015. THE PATIENT WAS REVISED ON (B)(6) 2023. EVERYTHING WAS REMOVED. 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 17680541 ↗
• InjuryAug 21, 2023Adverse 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 65 YO MALE, INITIAL RIGHT KNEE IMPLANTED ON (B)(6), 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2022, APPROXIMATELY 5 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. REASON FOR REVISION NOT REPORTED. POLY SWAP INDICATED. NO DEVICE BREAKAGE OR SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS OR DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO DEVICE RETURNS AVAILABLE AS THE HOSPITAL KEPT THE DEVICE. NO FURTHER INFORMATION. PATIENT WAS REVISED TO EXACTECH DEVICES. (B)(6), 02-012-48-4009 - LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM; SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K111400. CONCOMITANTS: (B)(6), 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4; (B)(6), 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T; (B)(6), 200-02-35 - THREE PEG PATELLA 35MM.

  Patient problems: Insufficient Information

  MAUDE report 17587661 ↗
• InjuryJul 6, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL RIGHT TKA, THIS 61 Y/O MALE PATIENT WAS REVISED AND HAD A POLY INSERT SWAP. THE PATIENT PRESENTED IN SURGEON OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA'S. THE PATIENT HAS RECALLED IMPLANTS IN BOTH KNEES. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION BILATERAL TKA POSSIBLE POLY SWAP VS FULL REVISION. LEFT TKA REVISION WAS CAPTURED IN 1038671-2023-01558. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS PROVIDED, UNABLE TO OBTAIN. IMAGES ATTACHED. NO PRODUCT RETURN; IMPLANTS WERE REQUIRED TO BE SENT TO THE LAB AT THE HOSPITAL AND THEN LEGAL.

  Patient problems: Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17265807 ↗
• InjuryMar 1, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE LEGAL DEPARTMENT THAT, THE POLYETHYLENE COMPONENTS WITHIN THE PATIENT KNEE PROSTHESES PREMATURELY DEGRADED OVER TIME CAUSING AN INFLAMMATORY RESPONSE RESULTING IN OSTEOLYSIS. THE PATIENT WILL UNDERGO A REVISION SURGERY DUE TO SEVERE PAIN, SWELLING, AND INSTABILITY IN THE KNEE AND LEG. THIS DEVICE WAS PART OF THE RECALL.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16459132 ↗
• InjuryNov 10, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN 80 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION ON (B)(6) 2022, APPROXIMATELY 3 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE FULL KNEE WAS REVISED. LOOSENING OF FEMUR DUE TO SIGNIFICANT POLY WEAR (PATELLA AND TIBIA) WERE INDICATED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICES RETURNING AS THEY WERE DISPOSED OF BY THE HOSPITAL.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 15777355 ↗
• InjuryOct 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2017. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO THE RECALL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15526201 ↗
• InjuryDec 14, 2021Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  AS REPORTED, APPROXIMATELY 5.5 YRS POSTOP THE INITIAL L TKA THIS (B)(6) FEMALE PATIENT WAS SCHEDULED FOR A REVISION DUE TO INCREASE WEAR. DURING SURGERY WE NOTICED THAT THE INSERT WAS MOVING WITHIN THE TIBIAL TRAY. THE POLY WAS REMOVED AND A NEW SIZE 4 / 9MM NEUTRAL WAS INSERTED AND STILL HAD THE SAME ISSUE THE POLY APPEARED NOT TO BE LOCKING INTO THE TIBIAL TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant; Implant Pain; Loss of Range of Motion; Osteolysis

  MAUDE report 13006052 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 4 YRS POSTOP THE INITIAL IMPLANT, THE (B)(6) Y/O FEMALE PATIENT EXPERIENCE KNEE PAIN, AND THE RIGHT KNEE WAS REVISED DUE TO INSTABILITY OF THE TIBIA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISPOSED BY THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 12192987 ↗

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