Optetrak Logic 02-012-35-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10885862001849), received between Oct 30, 2020 and Jan 28, 2025 — classified as 42 injuries.

The most frequently reported specific device problem is “Naturally Worn” (37 reports).

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

1 other recall cover devices cleared under the same FDA submission (K093360); 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2025Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED APPROXIMATELY 3 YEARS 9 MONTHS POST OPERATION DUE TO PROSTHESIS WEAR. NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21256649 ↗
• InjuryJan 23, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, THE PATIENT EXPERIENCED PAIN IN THEIR KNEE. DURING EXAMINATION, INSTABILITY WAS FOUND. IN THE RADIOLOGICAL STUDY, THE IMAGE IS COMPATIBLE WITH PET WEAR, WEAR OF THE PATELLAR COMPONENT, MASSIVE OSTEOLYSIS IN RELATION TO THE TIBIAL COMPONENT, AND TESTS COMPATIBLE WITH ASEPTIC DISIMPLANTATION. NORMAL BLOOD METAL LEVELS. THE PATIENT WAS REVISED APPROXIMATELY 5 YEARS AND 1 MONTH POST THEIR INITIAL KNEE SURGERY. NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Granuloma; Joint Laxity; Osteolysis; Pain

  MAUDE report 21221498 ↗
• InjuryJan 15, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS AND 10 MONTHS POST INITIAL TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT EXPERIENCED PAIN IN THE OPERATED KNEE. DURING EXAMINATION, THE PATIENT HAD MULTIDIRECTIONAL INSTABILITY OF THE KNEE. IN RADIOLOGICAL STUDY, THE IMAGE WAS COMPATIBLE WITH POLYETHYLENE WEAR, WEAR OF THE PATELLAR COMPONENT, MASSIVE OSTEOLYSIS IN RELATION TO THE TIBIAL COMPONENT, AND TESTS COMPATIBLE WITH ASEPTIC DISIMPLANTATION. THE PATIENT HAD NORMAL BLOOD METAL LEVELS. IT WAS FURTHER NOTED THAT THE PATIENT EXPERIENCED SIGNIFICANT DISABILITY AND SURGICAL REVISION WAS PERFORMED TO AVOID INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 21161083 ↗
• InjuryNov 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 145 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 20682831 ↗
• InjuryOct 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A 69 YO MALE PATIENT, INITIAL RIGHT TOTAL ARTHROPLASTY IN (B)(6) 2016, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 7 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. SINCE (B)(6) 2023, THE PATIENT HAD SUFFERED FROM RIGHT KNEE PAIN: THE KNEE WAS SWOLLEN WHEN HE WALKED FOR 30 MINUTES, CYCLED, STOOD STATICALLY FOR MORE THAN 20 MINUTES OR DROVE. TAKING PAINKILLERS AND CORTISONE DID NOTHING TO CHANGE THIS SITUATION; THE PATIENT LAY OR SAT WITHOUT BEING ABLE TO DO ANY SPORT, GO OUT OR TRAVEL. HE COULD DO SOME LIMITED DOMESTIC CHORES: SHOPPING, HOUSEWORK AND GARDENING. ON (B)(6) 2024, THE PATIENT CONSULTED HIS SURGEON, WHO DECIDED TO OPERATE ON (B)(6) 2024. THE SURGEON PERFORMED A REVISION OF THE RIGHT TOTAL KNEE PROSTHESIS WITH AN ENLARGED SYNOVECTOMY AND BONE RECONSTRUCTION. THE ENTIRE PROSTHESIS WAS COMPLETELY REPLACED BY A SEMI-CONSTRAINED PROSTHESIS, DUE TO FEMORAL AND TIBIAL LOOSENING. THE SURGEON TOLD THE PATIENT THAT THE PROSTHESIS WAS DEFECTIVE. ON DISCHARGE, THE PATIENT WAS HOSPITALIZED FOR THREE WEEKS AT HOME WITH DRESSING AND PHYSIOTHERAPY. HE RESUMED DRIVING ON (B)(6) 2024, AND SOME ACTIVITIES IN (B)(6) 2024.

  Patient problems: Joint effusion; Osteolysis; Pain

  MAUDE report 20521837 ↗
• InjuryOct 21, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 136 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS, NEGATIVELY AFFECTED MOBILITY, QUALITY OF LIFE, REVISION SURGERY, PAIN DURING SURGERY AND REHABILITATION, PHYSICAL THERAPY, LIMITED ABILITY TO PERFORM NORMAL DAILY ACTIVITIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

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

  MAUDE report 20499058 ↗
• InjuryOct 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 25 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FAILURE OF IMPLANT, POLYETHYLENE INSERT WEAR. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 20391169 ↗
• InjuryAug 30, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT UNKNOWN LENGTH OF TIME AFTER AN IMPLANT REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20108237 ↗
• InjuryAug 22, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 156 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY; SIGNIFICANT SYNOVITIS, GROSS LOOSENING OF THE FEMUR. 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: Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20033537 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DIFFICULTY WITH EVERYDAY ACTIVITIES, TROUBLE WALKING. 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; Pain

  MAUDE report 20006528 ↗
• InjuryJul 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 121 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND DEBILITATION, MODERATE EFFUSION, LOOSENING OF FEMUR, SEVERE FEMORAL OSTEOLYSIS, SEVERE WEAR OF POLYETHYLENE LINER AND PATELLA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANTS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19668274 ↗
• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DAILY PAIN AND DISCOMFORT, LIMITED DAILY ACTIVITIES, IMPACTED QUALITY OF LIFE; DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE; OTHER INJURIES PRESENTLY UNDIAGNOSED, ONGOING MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; PAIN AND SUFFERING. 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; Balance Problems; Discomfort; Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19655862 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2015, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19510880 ↗
• InjuryJun 11, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR PAIN, SWELLING, DECREASED ROM, MENTAL ANGUISH, EMOTIONAL DISTRESS, FEAR, LOSS OF ENJOYMENT OF LIFE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Implant Pain; Loss of Range of Motion; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 19509711 ↗
• InjuryJun 5, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 123 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEARPAIN, WEAKNESS, SWELLING, LIMITED ROM, LOSS OF MOBILITY, CLICKING/CATCHING OF THE KNEE. 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; Insufficient Information; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19471491 ↗
• InjuryJun 5, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 64 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY. IT WAS OBSERVED THERE WAS ¿LARGE AMOUNTS OF WEAR¿ ON THE POLYETHYLENE TIBIAL INSERT, AS WELL AS ¿A LOT OF REACTIVE SYNOVIAL TISSUE WITH GRANULATION.¿ THE OPERATIVE SURGEON ALSO NOTED MECHANICAL LOOSENING OF THE FEMORAL IMPLANT, AND CAVITARY LESIONS ON THE FEMUR. THE OPERATIVE SURGEON REVISED THE RIGHT KNEE AND REPLACED THE TIBIAL AND FEMORAL COMPONENTS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19470415 ↗
• InjuryJun 4, 2024Mechanical Problem; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 128 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS COMPONENT LOOSENING. THE PATIENT WAS PRESENTED WITH SIGNIFICANT PERIPROSTHETIC OSTEOLYSIS AND ASEPTIC LOOSENING OF THEIR LEFT TOTAL KNEE ARTHROPLASTY WITH ASSOCIATED PAIN REFRACTORY TO COMPREHENSIVE NONOPERATIVE MANAGEMENT IN THE SETTING OF A RECALLED EXACTECH TOTAL KNEE DEVICE. DURING THE PROCEDURE THERE WAS NOTED SEVERE REACTIVE SYNOVITIS AND JOINT EFFUSION CONSISTENT WITH POLYETHYLENE WEAR AND COMPONENT LOOSENING. THE FEMORAL COMPONENT WAS GROSSLY LOOSE WITH COMPLETE DE-BONDING AND NO EVIDENCE OF AN IMPLANT-CEMENT INTERFACE. UPON REMOVAL OF THE CEMENT THERE WERE SEVERE CONTAINED OSTEOLYTIC DEFECTS INVOLVING THE BILATERAL FEMORAL CONDYLES. THE PATELLAR BUTTON WAS INSPECTED AND DETERMINED TO BE LOOSE. 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: Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 19457474 ↗
• InjuryMay 28, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 112 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ASEPTIC TIBIAL LOOSENING, 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: Failure of Implant; Implant Pain; Osteolysis; Pain

  MAUDE report 19403587 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 112 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19281579 ↗
• InjuryMay 7, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 117 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. THE REVISING SURGEON NOTED LOOSENING OF THE FEMORAL COMPONENT, AS WELL AS BONY DEFECTS IN BOTH THE FEMUR AND TIBIA. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19261711 ↗
• InjuryFeb 20, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2017, APPROXIMATELY 6 YEARS, 9 MONTHS AFTER INITIAL IMPLANT. UPON THE REVISION OF THE EXACTECH DEVICE, SIGNS OF DELAMINATION OXIDATION AND WEAR OF THE TIBIAL POLYETHYLENE WERE OBSERVED. SIGNS THAT THE FEMORAL COMPONENT WAS GROSSLY LOOSE, AND MASSIVE DESTRUCTION AND LOSS OF THE FEMORAL BONE, POSTERIOR CONDYLES, AND DISTAL CONDYLES WERE ALSO OBSERVED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Foreign Body Reaction; Inadequate Osseointegration; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 18739627 ↗
• InjuryNov 1, 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) 2015. THIS HAS NOT BEEN EXPLANTED. THE PATIENT EXPERIENCES SEVERE PAIN AND DISCOMFORT AND DIFFICULTY WITH MOBILITY. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Pain

  MAUDE report 18047582 ↗
• InjurySep 14, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2013. APPROXIMATELY 9 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES INCLUDING BUT NOT LIMITED TO PAIN. 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

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information; Joint effusion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 17743123 ↗
• InjurySep 5, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 5 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. PRINCIPAL DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT DUE TO MECHANICAL LOOSENING. POST-OP DIAGNOSIS: SAME. SIGNIFICANT FIBRINOUS DEBRIS WAS ENCOUNTERED INTO THE JOINT WITH A TANDEM WHITISH COLOR THIS TISSUE WAS HIGHLY FRIABLE WAS FOUND THROUGHOUT THE SUPRAPATELLAR POUCH AS WELL AS IN THE GUTTERS. THIS WAS EXCISED AND THE KNEE IN ORDER TO FULLY DEBRIDED TO VISUALIZE ALL THE COMPONENTS THEN REMOVES SIMILAR DEBRIS FROM THE ANTERIOR INTERVAL AS WELL AS DID ARE NORMAL MEDIAL RELEASE. WE THEN REMOVED THE POLYETHYLENE INSERT WITH A SINGLE PRONG RETRACTOR. THE POLY WAS NOTED TO BE YELLOW WITH SIGNIFICANT PITTING AND LOSS OF THICKNESS IN THE MEDIAL LATERAL COMPARTMENT WITH CENTRAL PITTING AND ROUGHNESS NOTED ON BOTH THE MEDIAL AND LATERAL DWELL POINTS. TH

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 17684050 ↗
• InjuryAug 31, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2011. APPROXIMATELY 11 YEARS AND 8 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: PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC RIGHT KNEE JOINT A THOROUGH SYNOVECTOMY WAS PERFORMED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Osteolysis

  MAUDE report 17660079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093360. One submission often covers many models, so check the product and lot details in each record.

• Z-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ