Optetrak Logic 02-012-49-4009Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10885862174512), received between Apr 26, 2022 and Jan 7, 2025 — classified as 20 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

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

  LEGAL CASE RK REV AS REPORTED VIA LEGAL DOCUMENTATION, ON OR ABOUT (B)(6) 2019, THIS PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS IN HIS RIGHT KNEE. AT SOME POINT AFTERWARD, THE PATIENT PRESENTED TO THEIR DOCTOR FOR AN EVALUATION OF HIS RIGHT KNEE, AS HE HAD BEEN COMPLAINING OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN. ON OR ABOUT (B)(6) 2022, THE PATIENT UNDERWENT REVISION SURGERY OF HIS RIGHT KNEE DUE TO IMPLANT LOOSENING AND SIGNIFICANT SYNOVITIS. DURING THE REVISION SURGERY, THE SURGEON NOTED THAT THERE WAS "INFLAMMATORY SYNOVITIS INVOLVING THE SUPRAPATELLAR POUCH, MEDIAL AND LATERAL GUTTER" AND THAT THERE WAS "SOME EROSION AFFECTING THE MEDIAL AND LATERAL ASPECT OF THE POLYETHYLENE LINER" THE SUBSEQUENT POST-OPERATIVE DIAGNOSIS CONFIRMED THAT THE PLAINTIFF'S RIGHT TOTAL KNEE ARTHROPLASTY FAILED DUE TO SIGNIFICANT LOOSENING, WHICH IS RELATED TO THE FAILURE IN THE POLYETHYLENE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO FURTHER 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. EBI I

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21092313 ↗
• InjuryOct 10, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 7 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT PRESENTED TO THE SURGEON'S OFFICE COMPLAINING ABOUT THEIR LEFT KNEE. THE PATIENT REPORTED PAIN, INSTABILITY AND DISSATISFACTION. THE PATIENT HAS A RECALLED POLY INSERT. THE X-RAY SHOWS OSTEOLYSIS. THE PATIENT UNDERWENT REVISION SURGERY AND THE FEMORAL COMPONENT AND POLY WERE REVISED. THE PATIENT WAS REVISED TO FEMORAL CC REVISION COMPONENT AND PSC POLY IMPLANT. THE SURGEON WANTED TO UPSIZE THE FEMUR COMPONENT KNOWING THAT IT IS OFF-LABEL IF KEEPING THE CURRENT TIBIA IMPLANT. THE TIBIA COMPONENT WAS WELL FIXED AND THE SURGEON TRIALED A PSC POLY IMPLANT FOR THAT SIZE TIBIA. THE SURGEON WAS HAPPY WITH THE ARTICULATION AND STABILITY. THE PATIENT WAS IMPLANTED WITH THE REVISION COMPONENTS AND LEFT THE OR STABLE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. RELATED REPORT: 1038671-2024-03848.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 20416158 ↗
• InjurySep 19, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 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 20255877 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 52 MONTHS AFTER A RIGHT 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: Insufficient Information

  MAUDE report 20033119 ↗
• InjuryJul 24, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY AND THEN APPROXIMATELY 7 YEARS LATER EXPERIENCED A REVISION SURGERY. REVISION OPERATIVE REPORT -PREOPERATIVE DIAGNOSES: 1. FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO POLYETHYLENE BREAKDOWN AND SUBSEQUENT CYSTIC CHANGES TO BOTH THE FEMUR AND THE TIBIA, RESULTING IN LOOSENING OF THE RIGHT TOTAL KNEE PROSTHESIS. 2. CHRONIC RIGHT KNEE PAIN AS A RESULT OF DIAGNOSIS #1. THE PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. THE RIGHT KNEE CLINICALLY AND RADIOGRAPHICALLY DEMONSTRATED FAILURE. HARDWARE REMOVED: AN EXACTECH TOTAL KNEE REPLACEMENT SYSTEM WAS REMOVED. AT THE TIME OF THE REMOVAL, THERE WAS GROSS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. THERE WERE CYSTIC DEGENERATIVE CHANGES THROUGHOUT THE TIBIA AND WITHIN THE FEMUR BOTH MEDIALLY AND LATERALLY, AND THERE WAS COMPLETE BREAKDOWN OF THE POSTEROMEDIAL TIBIAL TRAY WITH SUBSEQUENT METALLOSIS FROM METAL-ON-METAL CONTACT OF THE FEMORAL COMPONENT ON THE TIBIAL COMPONENT, RESULTING IN METALLOSIS VILLONODULAR SYNOVITIS THROUGHOUT THE KNEE. ENCOUNTERED VILLONODULAR SYNOVITIS CLASSICALLY SEEN WITH METALLOSIS THAT WAS BLACKENED IN COLOR. VILLONODULAR S

  Patient problems: Cyst(s); Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 19822463 ↗
• InjuryJul 23, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(6)) THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO.(B)(6). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19811157 ↗
• InjuryMay 23, 2024Naturally Worn; Naturally Worn

  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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19387911 ↗
• InjuryApr 15, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 78 YO MALE PATIENT, INITIAL LEFT TOTAL KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 7 YEARS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED FOR A REVISION TKA POSSIBLE POLY SWAP VS. FULL REVISION. THE PATIENT HAD REVISION SURGERY AND WAS REVISED TO A TRULIANT TIB IMP CRC INSERT 9 MM SN: (B)(6). THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. THEY WERE DISCARDED BY THE FACILITY. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Implant Pain; Inflammation; Joint Laxity

  MAUDE report 19111697 ↗
• InjuryFeb 22, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL RIGHT TKA, THE 75 Y/O MALE PATIENT HAD A REVISION DUE TO POLY WEAR. PATIENT WAS REVISED TO A CRC LINER. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICE WAS DISPOSED BY THE HOSPITAL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18764643 ↗
• InjuryJan 9, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2019. APPROXIMATELY 4 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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) 2023 DIAGNOSIS: POLYETHYLENE OF RIGHT KNEE PROSTHESIS THERE IS VERY SIGNIFICANT SYNOVITIS IN THE MEDIAL GUTTER AND THE LATERAL GUTTER PROXIMAL OF THE PATELLOFEMORAL JOINT AND ANTERIOR TO THE MEDIAL JOINT AND ANTERIOR TO THE LATERAL JOINT LINE. IT HAD A VERY HYPERTROPHIC APPEARANCE. THE POLYETHYLENE COMPONENT CAME OUT. IT WAS VERY WORN BOTH MEDIALLY AND LATERALLY. THE PATIENT WAS TRANSFERRED TO GURNEY AND TAKEN TO THE RECOVERY ROOM.

  Patient problems: Failure of Implant

  MAUDE report 18473752 ↗
• InjuryJan 8, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TKA, THE 56 Y/O MALE PATIENT WAS REVISED DUE TO POLYETHELENE WEAR AND FEMORAL LOOSENING, AS A RESULT OF OSTEOLYSIS. THE PATIENT WAS REVISED TO A LOGIC CEM PS FEMUR SIZE 4 AND A SIZE 4 TIBIAL INSERT. THERE WAS 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 DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED AT HOSPITAL.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18467592 ↗
• InjuryDec 6, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST OP INITIAL RIGHT TKA, THIS 77 Y/O MALE PATIENT WAS REVISED. PATIENT PRESENTED TO SURGEON WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS. FULL REVISION. THE PATIENT UNDERWENT A TIBIAL INSERT POLY IMPLANT SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISCARDED BY THE FACILITY.

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

  MAUDE report 18276582 ↗
• InjuryAug 30, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL LEFT TKA, THE 66 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR. THE FEMUR AND LINER WERE EXCHANGED. 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 FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED BY THE HOSPITAL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17651774 ↗
• InjuryJul 25, 2023Naturally Worn; Naturally Worn

  REVISION OP REPORT ON (B)(6) 2023 DIAGNOSIS: POLYETHYLENE OF RIGHT KNEE PROSTHESIS THERE IS VERY SIGNIFICANT SYNOVITIS IN THE MEDIAL GUTTER AND THE LATERAL GUTTER PROXIMAL OF THE PATELLOFEMORAL JOINT AND ANTERIOR TO THE MEDIAL JOINT AND ANTERIOR TO THE LATERAL JOINT LINE. IT HAD A VERY HYPERTROPHIC APPEARANCE. THE POLYETHYLENE COMPONENT CAME OUT. IT WAS VERY WORN BOTH MEDIALLY AND LATERALLY. THE PATIENT WAS TRANSFERRED TO GURNEY AND TAKEN TO THE RECOVERY ROOM. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 17393944 ↗
• InjuryJul 12, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THE SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 10 YEARS 1 MONTH AFTER THEIR PRIMARY PROCEDURE. THE PATIENT HAS CLAIMED THE FOLLOWING INJURIES, INCLUDING BUT NOT LIMITED TO, SEVERE PAIN, INSTABILITY, MULTIPLE FALLS, ASEPTIC LOOSENING, HAVING TO UNDERGO REVISION SURGERY. 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: Failure of Implant; Insufficient Information; Joint Laxity; Osteolysis; Pain

  MAUDE report 17309785 ↗
• InjuryJun 19, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO A WORN POLY AND INFECTED TISSUE. 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

  MAUDE report 17159840 ↗
• InjuryMay 11, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 68 Y/O FEMALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022 DUE TO PAIN AND SWELLING. 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. REVISION OP REPORT. 10 MAY 2023/ K MCGUINNESS RECEIVED VIA LEGAL 18 APR 2023. DIAGNOSIS: FAILED RIGHT KNEE ARTHROPLASTY SECONDARY TO POLY WEAR. DURING THE PROCEDURE THERE WAS EXTENSIVE SYNOVITIC CHANGES BUT NO EVIDENCE OF METALOSIS. AN EXTENSIVE AND METICULOUS SYNOVECTOMY WAS PERFORMED. THE POSTERIOR PORTION OF POLY WAS THINNED BUT NOT FRACTURED. STERILE DRESSING WAS APPLIED. THE PATIENT WAS BROUGHT TO RECOVERY IN STABLE CONDITION.

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

  MAUDE report 16909857 ↗
• InjuryMar 28, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A MALE PATIENT, WHO HAD AN INITIAL RIGHT TOTAL KNEE REPLACEMENT ON (B)(6), 2013, AND WAS IMPLANTED WITH OPTETRAK LOGIC DEVICES, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2019, APPROXIMATELY 6 YEARS POST THE INITIAL PROCEDURE. FOLLOWING A PERIOD OF POST-IMPLANTATION RECOVERY, AND FOR YEARS AFTER THE REPLACEMENT SURGERY, THE PATIENT¿S KNEE DEVICE PERFORMED AS EXPECTED. THE PATIENT UNDERWENT REVISION OF THE RIGHT KNEE DEVICES, SECONDARY TO COMPLETE POLYETHYLENE LINER WEAR RESULTING IN ASEPTIC LOOSENING WITH MASSIVE SOFT TISSUE DAMAGE AND OSTEOLYSIS REQUIRING SIGNIFICANT BONE GRAFTING AND AUGMENTED REVISION COMPONENTS. ADDITIONALLY, THE LEGAL BRIEF INDICATES THAT DESPITE UNDERGOING THE REVISION SURGERIES, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT THEIR ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS THEIR QUALITY OF LIFE. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT, AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; METALLOSIS; SOFT TISSUE DAMAGE; INFECTION; AND OTHER I

  Patient problems: Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 16628321 ↗
• InjurySep 14, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 59 YO MALE PATIENT, WHO HAD A PRIMARY RIGHT TKA EXACTECH CR ON THE RIGHT KNEE ON (B)(6) 2015, PRESENTED TO THE OFFICE DISSATISFIED. THE PATIENT STATED THEY WERE NEVER REALLY HAPPY WITH THE KNEE REPLACEMENT POST OPERATIVELY, AND PRESENTED WITH CURRENT PAIN, STIFFNESS, AND AFTER X-RAY EXAMINATION SIGNS OF OSTEOLYSIS AFFECTING THE BONE. THE PATIENT WAS NEGATIVE FOR ANY PRE-OP INFLAMMATORY TESTING. THE POLY INSERT INITIALLY IMPLANTED WAS RESEARCHED WITHIN THE KNEE POLY RECALL DATABASE AND IS A POLY THAT IS AFFECTED BY THE RECALL. REVISION SURGERY PERFORMED ON (B)(6) 2022, APPROXIMATELY 7 YEARS 1 MONTH POST THE INITIAL IMPLANT PROCEDURE. THE SURGEON OPENED THE PRIMARY CR TKA INCISION, PERFORMED A SYNOVECTOMY, EXAMINED THE KNEE JOINT, THEN REMOVED THE ORIGINAL SLOPE ++ 9MM POLY. THE POLY HAD A SMALL AMOUNT OF WEAR AND PITTING AND OXIDATION DIRECTLY AT THE ARTICULAR SURFACE, SOME WEAR ON THE EDGE BUT A MOSTLY INTACT IMPLANT. THE METAL COMPONENTS WERE CHECKED WITH A BONE TAMP AND SHOWED TO BE WELL FIXED. THE SURGEON CLEANED UP THE BACK OF THE KNEE JOINT AND CONTINUED A SYNOVECTOMY. THEN REQUESTED TO TRIAL A 9MM CRC POLY TRAIL. THE 9MM CRC TRAIL FOR THE SIZE 4 WAS TAK

  Patient problems: Osteolysis; Pain; Unspecified Musculoskeletal problem

  MAUDE report 15420887 ↗
• 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) MALE PATIENT UNDERWENT A REVISION FOR AN UNKNOW REASON. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14212883 ↗

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