Optetrak Logic 02-012-48-1509Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862144379), received between Apr 26, 2022 and May 6, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, THE 76 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. 5 YEARS LATER, THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED WEAR OF THE TIBIAL INSERT AND THE PATIENT WAS REVISED ON (B)(6) 2024. BREAKAGE AND WEAR WERE OBSERVED IN THE RETRIEVED TIBIAL INSERT. THE SURGEON DID NOT FIND METALLOSIS. THERE WAS NO PROBLEM WITH THE LOCKING MECHANISM OF THE TIBIAL TRAY. POLYETHYLENE PARTICLES AND ALL PROLIFERATIVE TISSUE WAS REMOVED AND THE INSERT WAS REPLACED TO A NEW CR 9MM. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

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

  MAUDE report 19256301 ↗
• InjuryAug 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 67 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE POLY RECALL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS OR PHOTOS PROVIDED, UNABLE TO OBTAIN. NO PRODUCT RETURN; HOSPITAL KEPT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17563563 ↗
• InjuryJul 31, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A BILATERAL ON (B)(6) 2016. FOLLOWING THE SURGERIES, THE PATIENT BEGAN EXPERIENCING SEVERE PAIN, SWELLING, AND UNSTEADINESS IN BOTH KNEES, AND SIGNIFICANT GAIT IMPAIRMENT. THE PATIENT CONTINUED TO HAVE PAIN, SWELLING, AND DISCOMFORT IN HER RIGHT KNEE. X-RAYS WERE ¿SUGGESTIVE OF POSSIBLE WEAR OF POLYETHYLENE OF THE KNEE.¿ ON (B)(6) 2022 THE PATIENT UNDERWENT A RIGHT KNEE REVISION SURGERY. THE SURGEON¿S OPERATIVE FINDINGS INCLUDED ¿SOME ARTHROFIBROSIS OF [PATIENT'S] RIGHT TOTAL KNEE ARTHROPLASTY¿ AND ¿WEAR NOTED ON THE POLYETHYLENE OF THE RIGHT TOTAL KNEE ARTHROPLASTY.¿

  Patient problems: Discomfort; Failure of Implant; Implant Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 17425035 ↗
• InjuryJul 31, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A BILATERAL KNEE REPLACEMENT ON (B)(6) 2016. FOLLOWING THE SURGERIES, THE PATIENT BEGAN EXPERIENCING SEVERE PAIN, SWELLING, AND UNSTEADINESS IN BOTH KNEES, AND SIGNIFICANT GAIT IMPAIRMENT. DUE TO THIS WORSENING PAIN AND INSTABILITY CAUSED BY THE ACCELERATED WEAR OF HER IMPLANT, THE PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY ON (B)(6) 2020. DURING HER LEFT KNEE REVISION SURGERY, THE PATIENT'S SURGEON NOTED ¿SOME WEAR OF THE TIBIAL BASEPLATE¿ AND ¿SIGNIFICANT WEAR OF THE TIBIAL INSERT.¿ THE PATIENT'S SURGEON DISCOVERED ¿SIGNIFICANT METALLOSIS IN THE JOINT,¿ ¿DEPOSITION OF METALLOSIS IN THE SOFT TISSUE AND IN THE BONES OF THE KNEE JOINT,¿ AND ¿SIGNIFICANT DESTRUCTION OF SOFT TISSUE AND BONE FROM THE METALLOSIS WHICH WAS PRESENT.¿ THE PATIENT'S SURGEON ALSO NOTED INCREASED ¿COMPLEXITY OF THE CASE¿ DUE TO THE ¿SIGNIFICANT METALLOSIS IN THE JOINT¿ WHICH ¿NECESSITATE[ED] SIGNIFICANT DEBRIDEMENT OF ARTHROFIBROTIC TISSUE WITH METALLOSIS.¿ THE SURGEON DISCOVERED ¿SIGNIFICANT BONE LOSS, ESPECIALLY ON THE FEMORAL SIDE OF THE JOINT.¿ THESE ISSUES RESULTED IN AN ¿EXTENDED TIME NEEDED FOR SURGICAL INTERVENTION WITH SURGERY,¿ WITH THE REVISIO

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 17424186 ↗
• InjuryJun 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019 AND THEN APPROXIMATELY 3 YEARS, 10 MONTHS LATER, ON (B)(6) 2022, THEY EXPERIENCED A REVISION SURGERY FOR UNREPORTED REASONS. 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: Insufficient Information

  MAUDE report 17070863 ↗
• InjuryApr 18, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  LEGAL CASE (B)(6) RK REV. AS REPORTED VIA LEGAL DOCUMENTATION: PRE & POST OPERATIVE DIAGNOSIS: RIGHT TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE FAILURE. INDICATIONS FOR PROCEDURE: THE PATIENT IS A 79-YEAR-OLD FEMALE WITH HISTORY OF RIGHT TOTAL KNEE ARTHROPLASTY, WHICH INITIALLY PERFORMED WELL AND THEN RESULTANTLY STARTING TO HAVE PAIN AND EFFUSION. A WORKUP OF THE FUSION WITH ESR AND CRP WAS PERFORMED, WHICH WAS NEGATIVE FOR INFECTION AND ALSO A CT SCAN TO EVALUATE FOR OSTEOLYSIS AND LOOSENING, WHICH WAS NO SIGNIFICANT OF EITHER. MEDIAL PART OF THE POLYETHYLENE RECALL WITHIN THE FUSION THAT IS CONSTANT WITHOUT OTHERWISE ANY OTHER ETIOLOGY. THE PATIENT DID ALSO HAVE SOME ASYMMETRY ON THE POLYETHYLENE ON THE STANDING X-RAY. BECAUSE OF ALL THESE THINGS, THE NEED FOR POLYETHYLENE EXCHANGE AND ASSOCIATED SYNOVECTOMY WAS EXPRESSED. FROM PROCEDURE IN DETAIL: DURING MEDIAL PARAPATELLAR ARTHROTOMY, A LARGE AFFUSION WITH NO PURULENCE OR METALLOSIS COULD QUICKLY BE SEEN. UPON REMOVAL OF THE POLYETHYLENE, IT WAS STATED "WE COULD EASILY SEE DESTRUCTION OF THE MEDIAL COMPARTMENT WITH DELAMINATION AND PITTING AND DISCOLORATION OR FRACTURE OF THE POSTERIOR LIP OF THE POLYETHYLENE." INSPECTION OF TH

  Patient problems: Failure of Implant; Joint effusion; Pain

  MAUDE report 16765505 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Failure of Implant

  MAUDE report 14213050 ↗

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