Optetrak Logic 02-012-44-5009Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10885862173713), received between Aug 7, 2020 and Feb 19, 2025 — classified as 1 death, 38 injuries.

The most frequently reported specific device problem is “Naturally Worn” (28 reports).

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

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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2025Unstable; Unstable

  IT WAS REPORTED A PARTY STATED HE EXPERIENCED INSTABILITY, PAIN AND SWELLING IN HIS KNEE AFTER UNDERGOING REPLACEMENT SURGERY. INITIAL PROCEDURE IN (B)(6) 2020. THE PARTY¿S WIFE EXPRESSED THAT THE OVERALL EXPERIENCE HAS BEEN OFF-PUTTING. IT WAS ALSO NOTED BY THE PATIENT, THAT THEY UNDERWENT SURGICAL TREATMENT OF THE LEFT KNEE. IT IS UNKNOWN IF THEY WERE REFERRING TO THE INITIAL PROCEDURE OR IF THEY UNDERWENT A REVISION PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21407210 ↗
• InjuryJan 29, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 106 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BONE FRACTURE, DISCOMFORT, FAILURE OF IMPLANT, OSTEOLYSIS, AND PAIN. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Discomfort; Failure of Implant; Osteolysis; Pain

  MAUDE report 21264951 ↗
• InjuryJan 9, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 98 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS AND PAIN. REVISION 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain

  MAUDE report 21112315 ↗
• InjuryNov 11, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY NINE MONTHS POST INITIAL TOTAL KNEE ARTHROPLASTY, THE MALE PATIENT WAS SUFFERING FROM EVOLUTIVE SYNOVITIS. THE PATIENT WAS PRESENTING INSTABILITY WHEN WALKING, CHRONIC EFFUSION AND PATELLA LOOSENING. A SYNOVECTOMY WAS PERFORMED, THE LINER AND PATELLA WERE EXCHANGED. RELATED TO 1038671-2023-02987.

  Patient problems: Joint Laxity; Joint effusion; Synovitis

  MAUDE report 20659777 ↗
• InjuryOct 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A 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 20345322 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 49 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN AND EFFUSION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Pain

  MAUDE report 20068171 ↗
• InjuryAug 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 39 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR JOINT PAIN JOINT SWELLING AND STIFFNESS LIMITED RANGE OF MOTION LOSS OF MOBILITY REVISION SURGERY SYNOVITIS. 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; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19904962 ↗
• InjuryMay 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A 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 19427874 ↗
• DeathMay 20, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 102 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, A PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS WEAR OF THE POLYETHYLENE TIBIAL INSERT AND REPORTEDLY PASSED AWAY TWO DAYS AFTER THE PROCEDURE DUE TO UNSPECIFIED COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Insufficient Information; Joint Contracture; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 19353750 ↗
• InjuryApr 26, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2015 AND THEN WAS REVISED ON (B)(6) 2023. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, INSTABILITY, AND POLYETHYLENE WEAR. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

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

  MAUDE report 19194934 ↗
• InjuryApr 2, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, WITH NO REVISION SURGERY REPORTED. THERE IS NO DEVICE INFORMATION PROVIDED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Pain; Synovitis

  MAUDE report 19018149 ↗
• InjuryMar 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18967654 ↗
• InjuryOct 11, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2013. APPROXIMATELY 9 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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) 2022. DIAGNOSIS: PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC RIGHT KNEE JOINT THERE WAS SIGNIFICANT EFFUSION AND SYNOVITIS. NO PURULENCE. THERE WAS DELAMINATION OF THE POLYETHYLENE AND EVIDENCE OF PROSTHESIS LOOSENING OF THE FEMORAL COMPONENT. THE POLYETHYLENE WAS REMOVED. THERE WAS NO CEMENT ON THE BACKSIDE OF THE FEMORAL COMPONENT. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS ALLEGE THAT THEIR KNEE OR HIP REPLACEM

  Patient problems: Synovitis

  MAUDE report 17913067 ↗
• InjurySep 14, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2012. APPROXIMATELY 7 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), AND PENDING IN THE EASTERN DISTRICT OF (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Failure of Implant; Insufficient Information; Joint Laxity; Joint effusion; Synovitis

  MAUDE report 17745094 ↗
• InjurySep 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2017. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2020, APPROXIMATELY 2 YEARS 20 MONTHS POST PRIMARY PROCEDURE. THE PATIENT CLAIMS TO HAVE SUFFERED INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Pain

  MAUDE report 17731414 ↗
• InjuryJul 24, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION 55 Y/O MALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 7 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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) 2022. DIAGNOSIS: FAILED TOTAL KNEE ARTHROPLASTY. THE PATELLA WAS EVALUATED. IT HAD SOME MILD TO MODERATE WEAR LATERALLY. UPON REMOVAL OF THE POLY, IT WAS NOTED THAT THERE WAS NOT ANY MIDSUBSTANCE WEAR AND NO BACKSIDE WEAR, BUT THERE WAS SIGNIFICANT WEAR BOTH POSTERIOR, MEDIAL AND LATERAL AT THE EDGE LOADING POSTERIORLY. NOT SURE WHETHER THIS WAS DELAMINATION OF THE POLY OR SIMPLE WEAR FROM A POSTERIOR STABILIZED KNEE WITH IMPINGEMENT POSTERIORLY.

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

  MAUDE report 17379827 ↗
• InjuryJul 7, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014 AND THEN APPROXIMATELY 7 YEARS, 8 MONTHS LATER EXPERIENCED A SURGICAL REVISION PROCEDURE ON (B)(6) 2022. THE REVISION IS REPORTED TO BE FOR: JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, INSTABILITY, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, AND REVISION WITH BONE GRAFT. 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: Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 17277352 ↗
• InjuryJun 21, 2023Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2020. THE DEVICE HAS NOT YET BEEN EXPLANTED DUE TO FAILED TOTAL KNEE REPLACEMENT OF THE LEFT KNEE AND THE NEED FOR SURGICAL REVISION; CONSTANT SWELLING OF THE LEFT KNEE REQUIRING NEEDLE ASPIRATION; INFECTION; PAIN, SUFFERING, AND GAIT ABNORMALITY. 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: Ambulation or Postural Difficulties; Insufficient Information; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 17172534 ↗
• InjuryJun 12, 2023Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 AND THEN APPROXIMATELY 2 YEARS, 4 MONTHS LATER, ON 27 OCT 2022, THEY EXPERIENCED A REVISION SURGERY. REVISION OPERATIVE REPORT OF 27 OCT 2022. POST OPERATIVE DIAGNOSIS- FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR OF THE BEARING SURFACE. FINDINGS: THE PATIENT HAD INITIALLY DONE WELL, BY 2020 THE LEFT KNEE WAS BECOMING INCREASINGLY SWOLLEN, AND ANY INCREASED ACTIVITY DRAMATICALLY INCREASED THE AMOUNT OF SWELLING. HE PRESENTED IN 2022 AFTER THE RECALL WAS ANNOUNCED. ASPIRATION OF SYNOVIAL FLUID FROM HIS KNEE SHOWED A PATTERN CONSISTENT WITH ACCELERATED POLYETHYLENE WEAR. PREOPERATIVE X-RAY SHOWED THAT THE COMPONENTS WERE WELL FIXED. AT SURGERY THEY FOUND THE TYPICAL HYPERTROPHIC OVERGROWN SYNOVIUM WITH FOREIGN BODY REACTION TYPE APPEARANCE. THERE WAS SEVERE WEAR ON BOTH MEDIAL AND LATERAL POLYETHYLENE PLATEAUS. THERE WAS SOME OSTEOLYSIS UNDER THE TIBIAL TRAY, BUT THE TIBIAL AND FEMORAL COMPONENTS WERE WELL FIXED. DRESSINGS WERE APPLIED, THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. THERE IS NO OTHER PATIE

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17107440 ↗
• InjuryApr 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2014. OVER THE LAST TWO YEARS THE PATIENT HAS EXPERIENCED SWELLING AND INCREASING SENSATION OF INSTABILITY. FINDINGS WERE POLYETHYLENE WEAR MEDIALLY AND POSTERIORLY, AS WELL AS ON THE POST WITH SIGNIFICANT FOREIGN BODY SYNOVITIS DEBRIS NOTED, AND UNDERMINING OF THE FEMORAL AND TIBIAL COMPONENTS. THE PATIENT WAS REVISED ON (B)(6) 2022. THE RIGHT LEG HAD A LARGE EFFUSION. UPON ENTERING THE JOINT, THE FLUID APPEARED BENIGN. THIS WAS CULTURED AND GRAM STAIN RETURNED NEGATIVE. THERE WAS SIGNIFICANT POLYETHYLENE WEAR, SYNOVITIS THROUGHOUT THE KNEE, PROLIFERATIVE SYNOVITIS IN THE SUPRAPATELLAR POUCH, MEDIAL AND LATERAL GUTTERS. THE PATELLA WAS EVERTED. THIS WAS DEBRIDED AND THEN A SYSTEMATIC RESECTION OF THE SYNOVIUM IN THE SUPRAPATELLAR POUCH, MEDIAL AND LATERAL GUTTERS WAS CARRIED OUT. THE PATELLAR COMPONENT WAS WELL FIXED. IT WAS REMOVED AND THE POLYETHYLENE REMOVED TO REVEAL SIGNIFICANT WEAR ON THE POSTERIOR ASPECTS AS WELL AS ON THE POST, AND EVIDENCE OF YELLOWING AND WHITISH CRYSTALLINE FORMATION IN THE POSTERIOR ASPECT. THE FEMORAL COMPONENT WAS UNDERMINED ALTHOUGH NOT GROSSLY LOOSE. THE TIBIA WAS THE

  Patient problems: Failure of Implant

  MAUDE report 16740116 ↗
• InjuryApr 12, 2023Naturally Worn; Packaging Problem; Insufficient Device Problem Information; Naturally Worn; Packaging Problem; Insufficient Device Problem Information

  APPROXIMATELY, 6 YEAR AND 3 MONTHS AFTER INITIAL SURGERY, THE PATIENT HAD A LEFT KNEE REVISION ON 16 AUG 2022. 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 OPERATIVE REPORT FOR LEFT TOTAL KNEE ON (B)(6) 2022: PATIENT PRESENTS WITH PAIN AND SWELLING. THERE WAS A LARGE EFFUSION IN THE KNEE JOINT. POLY LINER WAS REMOVED. THE FEMORAL IMPLANT CAME OFF VERY EASILY AND WAS COMPLETELY DEBONDED FROM THE CEMENT. THERE WERE LARGE CYSTS IN THE POSTERIOR FEMORAL CONDYLES BOTH MEDICALLY AND LATERALLY. THE TIBIAL IMPLANT WAS REMOVED WITH MINIMAL BONE LOSS. THE PATELLAR IMPLANT WAS NOT LOOSE SO WAS NOT REVISED. DRESSINGS WERE APPLIED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM INS TABLE CONDITION.

  Patient problems: Cyst(s); Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16723858 ↗
• InjuryMar 1, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED WITH AN OPTETRAK POLYETHYLENE TIBIAL INSERT ON (B)(6) 2016, UNDERWENT REVISION SURGERY ON (B)(6) 2018, APPROXIMATELY 1 YEAR 7 MONTHS POST THE INITIAL PROCEDURE, DUE TO PREVENTABLE AND ACCELERATED WEAR OF THE OPTETRAK POLYETHYLENE TIBIAL INSERT. AS A RESULT OF THE DEFENDANTS¿ FAILURE TO PROPERLY PACKAGE THE DEVICE PRIOR TO DISTRIBUTION, THE POLYETHYLENE LINER PREMATURELY DEGRADED, AND THE PLAINTIFF REQUIRED REVISION SURGERY DUE TO SEVERE PAIN, SWELLING, AND INSTABILITY IN THE KNEE AND LEG. THESE INJURIES WERE CAUSED BY EARLY AND PREVENTABLE WEAR OF THE POLYETHYLENE INSERT AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS AND OTHER INJURIES. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE NATURE OF DEFENDANTS¿ DEVICE SURGICALLY IMPLANTED IN THE PLAINTIFF WHICH NECESSITATED PREMATURE REMOVAL, THE PLAINTIFF SUFFERED AND WILL CONTINUE TO SUFFER SERIOUS PERSONAL INJURIES, INCLUDING PAIN, IMPAIRED MOBILITY, REHABILITATION, MEDICAL CARE, LOSS OF ENJOYMENT OF LIFE, AND OTHER MEDICAL AND NON-MEDICAL SEQUELAE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16464957 ↗
• InjuryJan 19, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF, BEFORE (B)(6) 2013, PATIENT BEGAN MEDICAL TREATMENT LEFT KNEE ARTHRITIS. BEFORE (B)(6) 2013, THE ORTHOPAEDIC SURGEON INDICATED THAT THE PATIENT MET THE CRITERIA FOR A TOTAL KNEE REPLACEMENT ON HIS LEFT KNEE. ON OR ABOUT (B)(6) 2013, SURGEON IMPLANTED THE RECALLED OPTETRAK COMPONENTS INTO PATIENT'S LEFT KNEE. ON OR ABOUT (B)(6) 2022, PATIENT UNDERWENT SURGERY TO REMOVE THE OPTETRAK AND REPLACED IT WITH ANOTHER IMPLANT. ON OR ABOUT (B)(6) 2022, SURGEON FOUND THAT THE RECALLED OPTETRAK POLYETHYLENE FAILED. NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16208189 ↗
• InjuryDec 29, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 71 YO MALE, HAD AN INITIAL RIGHT KNEE IMPLANT ON, (B)(6) 2015, THEN HAD THEIR POLY INSERT REVISED ON (B)(6) 2022, APPROXIMATELY 7 YEARS 3 MONTHS POST THE INITIAL PROCEDURE FOR INSTABILITY AND POTENTIAL POLY WEAR. THERE WERE NO REPORTED ISSUES WITH THE REVISION PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. "THE CASE WENT FINE." NO PRODUCT RETURN ANTICIPATED AS THE HOSPITAL IS KEEPING THE INSERT. NO ADDITIONAL INFORMATION.

  Patient problems: Joint Laxity

  MAUDE report 16068464 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED BY LEGAL TEAM, APPROXIMATELY 1.5 YEARS POST INITIAL LEFT SIDE TKA, THE MALE PATIENT HAD A REVISION FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15685288 ↗