Optetrak Logic 02-012-44-4009Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10885862173638), received between Aug 10, 2020 and Nov 24, 2025 — classified as 58 injuries.

The most frequently reported specific device problem is “Naturally Worn” (45 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MILD OSTEOLYSIS WAS PRESENT. THE PATELLA EXHIBITED SEVERE WEAR ALONG THE LATERAL TRACKING PATH. THE TIBIAL INSERT HAD SEVERE WEAR ON THE MEDIAL AND LATERAL ARTICULAR SURFACE, AND POSTERIOR OF POST. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE TIBIAL AND FEMORAL COMPONENTS WERE RETAINED WHILE THE PATELLA AND TIBIAL INSERT WERE REPLACED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 23632080 ↗
• InjurySep 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED THAT THE PRODUCT IN THEIR KNEE WAS NOT GOOD AND THEIR DOCTOR ADVISED THEM TO HAVE A REPLACEMENT DUE TO THE IMPLANT BEING BROKEN INTO PIECES. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 12 YEARS AND 10 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22963822 ↗
• InjuryMar 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 7 YEARS 2 MONTHS POST INITIAL OPERATION. SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MILD OSTEOLYSIS WAS PRESENT. PATELLA EXHIBITED MILD WEAR ALONG LATERAL TRACKING PATH. TIBIAL INSERT HAD MILD WEAR MEDIALLY AND POSTERIOR TO POST. FEMORAL AND TIBIAL COMPONENT WERE WELL FIXED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 21632403 ↗
• InjuryMar 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 78 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Insufficient Information; Osteolysis; Pain

  MAUDE report 21526404 ↗
• InjuryJan 13, 2025Naturally Worn; Naturally Worn

  LEGAL CASE-USA. PATIENT ID: (B)(6). AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AND 8 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: PRIMARY ARTHRITIS AND MECHANICAL LOOSENING OF RIGHT PROSTHETIC JOINT THE FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE. THE FEMORAL COMPONENT WAS REMOVED WITHOUT DIFFICULTY. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO THE RECOVERY UNIT. EBI INITIAL SURGERY UNABLE TO BE LOCATED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. OPERATIVE REPORT FROM REVISION SURGERY ATTACHED. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT FOR POLYETHYLENE ISSUES OCCURRED IN THE US. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR AUSTRALIA, BRAZIL, CANADA, EEA/EU, JAPAN, TAIWAN, OR GREAT BRITAIN, EXCLUDING NORTHERN IRELAND. THEREFORE, ONLY THE US REPORTABILITY DETERMINATION WILL

  Patient problems: Scar Tissue; Synovitis

  MAUDE report 21138422 ↗
• InjuryDec 31, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 105 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, INSTABILITY, AMBULATION OR POSTURAL DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, JOINT LAXITY, IMPLANT PAIN, FAILURE OF IMPLANT, OSTEOLYSIS, AND SCAR TISSUE. INITIAL SURGERY AND 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: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Scar Tissue

  MAUDE report 21047705 ↗
• InjuryDec 31, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 60 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, PAIN, JOINT LAXITY, OSTEOLYSIS, SWELLING AND EDEMA.. 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; Osteolysis; Synovitis

  MAUDE report 21047611 ↗
• InjuryDec 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 5 YEARS AND 5 MONTHS AFTER INITIAL IMPLANT. THERE IS NO DEVICE INFORMATION PROVIDED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Osteolysis

  MAUDE report 20879354 ↗
• InjuryAug 26, 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 127 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 20070671 ↗
• InjuryAug 15, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 77 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, CONSCIOUS PAIN AND SUFFERING, OSTEOLYSIS, ADVERSE REACTION, SWELLING, INSTABILITY, BONE LOSS, BONE RESORPTION, TISSUE DESTRUCTION, POLYEHTYLENE WEAR, DEBRIS, COMPONENT LOOSENING, ACCELERATED POLYETHYLENE WEAR, SERIOUS COMPLICATIONS, IMPAIRED MOBILITY, DEBILITATION, PHYSICAL DISABILITY, DISABILITIES OF ACTIVITIES OF DAILY LIFE, MEDICAL BILLS AND EXPENSES, MENTAL ANGUISH, PSYCHOLOGICAL AND EMOTIONAL DISTRESS, FEAR, LOSS OF THE ENJOYMENT OF LIFE, PECUNIARY LOSSES, LOSS OF WAGES, THE ANTICIPATED NEED TO UNDERGO UNNECESSARY AND TRAUMATIC REVISION SURGERY, AND OTHER MEDICAL CONDITIONS . 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; Distress; Emotional Changes; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19989968 ↗
• InjuryAug 14, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA. IT WAS REPORTED THAT APPROXIMATELY 72 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Shedding Debris; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19987671 ↗
• InjuryAug 13, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 109 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SUFFERING, PAST COST MEDICAL CARE, FUTURE COST OF MEDICAL CARE, LOSS OF EARNING CAPACITY AND MENTAL AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Osteolysis; Pain

  MAUDE report 19975777 ↗
• InjuryJul 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 95 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 19778940 ↗
• InjuryJun 20, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 104 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DAMAGED PATELLA, AND OSTEOLYSIS. 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; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19575750 ↗
• InjuryJun 19, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 21 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 19566096 ↗
• InjuryJun 18, 2024Unstable; Naturally Worn; Lack of Effect; Unstable; Naturally Worn; Lack of Effect

  IT WAS REPORTED THAT APPROXIMATELY 144 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, EFFUSION, SYNOVITIS, DELAMINATION OF THE TIBIAL POLYETHYLENE, WORN PATELLA, LOOSENING AND JOINT LAXITY. 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; Failure of Implant; Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 19561930 ↗
• InjuryApr 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROSCOPY ON (B)(6) 2020 AT LAWRENCE AND MEMORIAL HOSPITAL. THE PATIENT WAS LATER REVISED ON (B)(6) 2024 WITH DR CHRISTOPHER HUTCHINS (OP REPORT ATTACHED). THE ATTACHED REVISION OP REPORT SHOWED THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICE AND LEFT THE OPERATING ROOM IN STABLE CONDITIONS WITH NO COMPLICATIONS. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING, BUT NOT LIMITED TO, POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY AND/OR COMPONENT LOOSENING. THERE IS NO OTHER PATIENT MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO SPECIFIC DEVICE INFORMATION PROVIDED.

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

  MAUDE report 19176113 ↗
• InjuryApr 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 2 YEARS AND 4 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19094661 ↗
• InjuryMar 4, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2014. THIS DEVICE HAS NOT BEEN EXPLANTED. 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; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 18826335 ↗
• InjuryFeb 9, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL TKA, THE SURGEON DID A REVISION SURGERY ON THE MALE PATIENT ON (B)(6). THE PATIENT WAS SUFFERING FROM SWOLLEN KNEE AND PAINFUL KNEE DURING EXERCISE. THERE WAS NO RADIOLOGICAL ABNORMALITY. PATIENT HAD CHRONIC HYDROARTHRITIS SINCE ONE YEAR. A SYNOVECTOMY WAS PERFORMED AND THE POLYETHYLENE CHANGED. THE SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO PATIENT WANTS TO KEEP IT. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE METAL PARTS WERE SEALED WELL. THE PATELLA PE WAS NOTED TO BE ALMOST INTACT, BUT THE TIBIAL PE WAS WORN ON BOTH PLATES. THERE WERE NO DIFFICULTIES OR UNFORESEEN EVENTS ENCOUNTERED. THE ONE-PIECE SYNOVECTOMY WAS COMPLETED POSTERIORLY, AND THE CONTROL OF JOINT KINETICS WAS NOTED TO BE EXCELLENT. THE KNEE WAS STABLE, AND EVERYTHING WAS WELL ALIGNED WITH FULL EXTENSION FOR THE 11MM PS INSERT.

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

  MAUDE report 18679898 ↗
• InjuryOct 19, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT (B)(6) 2014. APPROXIMATELY 8 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION (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 (B)(6) 2023. DIAGNOSIS: LEFT KNEE FAILED TOTAL KNEE REPLACEMENT WITH RECALLED EXACTECH POLYETHYLENE, LEFT KNEE SYNOVITIS SECONDARY TO POLYETHYLENE WEAR, LEFT KNEE MINOR OSTEOLYSIS. THERE WAS VERY EXTENSIVE SYNOVITIS AND A VERY THOROUGH SYNOVECTOMY OF THE JOINT WAS PERFORMED. THE POLYETHYLENE LINER WAS REMOVED. THERE WAS NOTED TO BE SOME WEAR OF THE LINER WITH MARKED DELAMINATION MEDIALLY AND ON THE POST. NEXT THE FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED. THERE WAS NO EVIDENCE OF INFECTION GROSSLY ALTHOUGH MULTIPLE SPECIMENS WERE SENT TO PATHOLOGY. ATTENTION WAS THEN TURNED TO THE TIBIA WHICH WAS NOTED TO BE WELL FIXED. A FULL DEBRIDEMENT OF THE KNEE POSTERIORLY WAS PERFORMED TO REMOVE THE SYNOVITIS POSTERIORLY. THE PATELLA WAS NOTED TO BE WELL FIXED WITHOUT ANY SIGNIFIC

  Patient problems: Failure of Implant; Implant Pain; Joint effusion; Osteolysis; Synovitis

  MAUDE report 17966555 ↗
• InjuryOct 2, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 1 YEAR AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2017. UPON INFORMATION AND BELIEF, THE PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, INSTABILITY, AND COMPONENT LOOSENING. THE PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE WHICH LIMITED AND CONTINUES TO LIMIT HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE. 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 R

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Insufficient Information; Pain

  MAUDE report 17851976 ↗
• InjurySep 26, 2023Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. AFTER THE SURGERY, THE PATIENT SUFFERED PAIN, SWELLING, DISCOMFORT, DECREASED RANGE OF MOTION AND OTHER LIMITATIONS IN HIS LEFT KNEE. AFTER REVISION SURGERY POST-OPERATIVE DIAGNOSIS INCLUDED: LEFT KNEE FAILED TOTAL KNEE REPLACEMENT; LEFT KNEE ASEPTIC LOOSENING FEMORAL COMPONENT; AND LEFT KNEE OSTEOLYSIS. MDL NO. 3044. 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 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 EXACTE

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

  MAUDE report 17816430 ↗
• InjurySep 25, 2023Mechanical Problem; Naturally Worn; Insufficient Device Problem Information; Patient Device Interaction Problem; Mechanical Problem; Naturally Worn; Insufficient Device Problem Information; Patient Device Interaction Problem

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2012 DUE TO OSTEOARTHRITIS. APPROXIMATELY 3 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2016. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: FIBROUS ANKYLOSIS WITH MILD MIDRANGE LIGAMENTOUS LAXITY. THE SURGEON NOTED THERE WAS NO OBVIOUS LOOSENING OF THE FEMORAL OR TIBIAL COMPONENTS, NO MALROTATION. THERE WAS NO EVIDENCE OF SIGNIFICANT POLYETHYLENE WEAR OR POST IMPINGEMENT. THE PATELLOFEMORAL TRACKING WAS INTACT. THERE WAS SIGNIFICANT SCARRING ALMOST OBLITERATING THE PATELLA. UPON EXAMINATION, THE POLY WAS FOUND TO BE ACTUALLY INTACT. THERE WAS ABOUT 3 TO 4 MM OF MIDRANGE LAXITY MEDIALLY AND LATERALLY. 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.

  Patient problems: Ankylosis; Insufficient Information; Joint Laxity; Joint effusion; Scar Tissue

  MAUDE report 17809764 ↗
• InjuryJul 20, 2023Adverse 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 VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6), 2017. THEY HAD AN ARTHROSCOPY AND PARTIAL SYNOVECTOMY ON (B)(6), 2022. ON (B)(6), 2023 THEY UNDERWENT RIGHT KNEE REVISION SURGERY, APPROXIMATELY 6 YEARS 1 MONTH AFTER THEIR PRIMARY IMPLANTATION. ON (B)(6), 2022 OP REPORT: A CHLYSIS OF THE PATELLOFEMORAL JOINT WAS PERFORMED TO FREE UP FROM THE PATELLAR ENTRAPMENT. SCAR TISSUE WAS REMOVED SUPRAPATELLAR, MEDIAL AND LATERAL GUTTERS AND PERIPATELLAR. THE PATIENT HAD MINIMAL DEBRIS SYNOVITIS, WHICH WAS DEBRIDED. ON (B)(6), 2023 OP REPORT POSTOPERATIVE DIAGNOSIS: INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL ORTHOPEDIC DEVICE. CLEAR FLUID WAS ENCOUNTERED; THERE WAS NO PURULENCE. SURGEON NOTED SIGNIFICANT SCAR TISSUE IN BOTH THE MEDIAL AND LATERAL GUTTERS. 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 17357575 ↗