Optetrak Logic 02-012-44-5011Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10885862173720), received between Aug 8, 2020 and Oct 28, 2025 — classified as 39 injuries.

The most frequently reported specific device problem is “Naturally Worn” (31 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.

• InjuryOct 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY OF AN UNKNOWN SIDE. SUBSEQUENTLY, THE PATIENT REPORTED EXPERIENCING PAIN, SWELLING AND OSTEOLYSIS. AS A RESULT, THE PATIENT REPORTED THE NEED FOR AN ADDITIONAL SURGERY ON A FUTURE DATE. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 23406257 ↗
• InjurySep 5, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. (B)(4)) (NGG) (MMH) IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 125 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. INITIAL EBI SURGERY UNABLE TO BE FOUND.

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

  MAUDE report 20153317 ↗
• InjuryAug 23, 2024Unstable; Structural Problem; Naturally Worn; Unstable; Structural Problem; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS AND AORI 2A BONE ON LOSS FEMUR, DEBONDED FEMORAL. 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: Joint Laxity; Medical device site infection; Osteolysis; Synovitis

  MAUDE report 20046162 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POST THE INITIAL LEFT TKA, THE PATIENT WAS REVISED AND THE POLY AND PATELLA WERE EXCHANGED DUE TO WEAR. 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: Insufficient Information

  MAUDE report 19829367 ↗
• InjuryJul 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 75 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, WEAKNESS, NEGATIVELY AFFECTED QUALITY OF LIFE, AND LIKELY REVISION SURGERY; LIMITED ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES. 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; Pain

  MAUDE report 19793443 ↗
• InjuryJul 18, 2024Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 22 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR,JOINT PAIN JOINT SWELLING AND STIFFNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19775272 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 92 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ASEPTIC LOOSENING. THE PATIENT WAS INDICATED FOR SEVERE PAIN DUE TO FAILED ASEPTIC LOOSENING OF LEFT TOTAL KNEE REPLACEMENT. THE OPERATIVE REPORT INTRAOPERATIVE FINDINGS NOTE LOOSE FEMORAL IMPLANT REMOVED EASILY WITH MINIMAL BONE LOSS. THE BACKSIDE OF THE FEMORAL IMPLANT WAS 100% CLEAN WITHOUT ANY CEMENT ATTACHED. ALL OF THE CEMENT WAS ON THE DISTAL FEMUR. ON THE BACKSIDE OF THE CEMENT WAS SIGNIFICANT OSTEOLYSIS FROM POLY WEAR THAT HAD DESTROYED THE BONE. THERE WAS EXTENSIVE SOFT TISSUE DAMAGE THROUGHOUT THE KNEE JOINT AS A RESULT OF OSTEOLYSIS AS WELL. PATELLA BUTTON WAS WELL FIXED AND STABLE. 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; Osteolysis; Pain

  MAUDE report 19499617 ↗
• InjuryMay 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT/RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2021 APPROXIMATELY 3 YEARS AND 11 MONTHS AFTER INITIAL IMPLANT. THERE IS NO DEVICE INFORMATION PROVIDED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19229151 ↗
• InjuryOct 11, 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) 2016. 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, 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: Insufficient Information

  MAUDE report 17913413 ↗
• InjurySep 19, 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)2012. APPROXIMATELY 10 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. 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. 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 THA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 17775326 ↗
• InjurySep 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT UNDERWENT THEIR FIRST LEFT KNEE REVISION SURGERY ON (B)(6) 2020. THEY HAVE NOT YET UNDERGONE A SECOND REVISION SURGERY, BUT IT HAS BEEN CONFIRMED THAT THEY WERE RE-IMPLANTED WITH A SECOND RECALLED OPTETRAK LOGIC POLYETHYLENE TIBIAL INSERT. THE PATIENT CLAIMS TO SUFFER FROM INJURES 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 17731563 ↗
• InjuryAug 24, 2023Crack; Naturally Worn; Crack; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 10 YEARS 8 MONTHS AFTER THEIR INITIAL PROCEDURE. (B)(6) 2023 OP REPORT INTRAOPERATIVE FINDINGS INCLUDE LOOSE FEMORAL AND TIBIAL IMPLANTS - REMOVED EASILY WITH MODERATE BONE LOSS. THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE KNEE JOINT CONSISTENT WITH SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUE. THERE WERE TINY, SMALL BALLS OF LIGHT BROWN SYNOVIUM ALONG WITH A "PSEUDO-CAPSULE" OF DENSE SOFT TISSUE. THE SURGEON NOTED THERE WAS EXCESSIVE WEAR WITH SIGNS OF OXIDATION / YELLOW DISCOLORATION, PITTING, CRACKING, AND DELAMINATION OF THE POLYETHYLENE. DISTAL FEMORAL AND ANTERIOR FEMORAL BONE LOSS WAS MODERATE. TIBIAL BONE LOSS WAS EXTENSIVE AND REQUIRED PLACEMENT OF A TIBIAL CONE. 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; Failure of Implant; Implant Pain; Joint Laxity; Synovitis

  MAUDE report 17617908 ↗
• InjuryJul 27, 2023Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2020. APPROXIMATELY 1 YEAR AND 2 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 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO ARTHROFIBROSIS FINDINGS: EXTENSIVE SCAR TISSUE WAS FOUND ALONG THE LATERAL GUTTER WITH VERY THICKENED SCAR INVOLVING THE LATERAL COLLATERAL LIGAMENT, THE IT BAND, THE LATERAL PATELLAR RETINACULUM. THE POSTERIOR CAPSULE WAS EXTREMELY THICKENED AND SCARRED WITH SOME AREAS OF HETEROTOPIC CALCIFICATION, VERY, VERY THICKENED POSTERIOR CAPSULE SCAR. THE MEDIAL COLLATERAL LIGAMENT WAS INTACT. THERE WERE SIGNIFICANT ADHESIONS BETWEEN THE MEDIAL SKIN FLAP AND THE QUADRICEPS, AND THE QUADRICEPS IN THE REGION OF THE MID VASTUS INCISION WAS ALSO SIGNIFICANTLY SCARRED. AFTER MOBILIZING THE SCAR TISSUE, EXCISING MOST OF THE SCAR TISSUE FR

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

  MAUDE report 17406769 ↗
• InjuryJul 25, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A MALE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2014. APPROXIMATELY 8 YEARS 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: POLYETHYLENE PARTICULATE DEBRIS-INDUCED SYNOVITIS. AT THE TIME OF SURGERY, THERE WERE FOUND TO BE DISTINCTLY INFLAMED AND THICKENED SYNOVIUM CONSISTENT WITH REACTION TO POLYETHYLENE PARTICULATE DEBRIS. THERE WERE NO SIGNS OF INFECTION. FEMORAL, TIBIAL AND PATELLAR COMPONENTS WERE ALL WELL FIXED. INSPECTION OF THE POLYETHYLENE LINER DEMONSTRATES SOME WEAR ON THE POSTERIOR ASPECT BOTH MEDIALLY AND LATERALLY OF THE POLYETHYLENE LINER.

  Patient problems: Implant Pain; Joint effusion; Synovitis

  MAUDE report 17390188 ↗
• InjuryJun 28, 2023Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2014. APPROXIMATELY 2 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2017 DUE TO PAIN AND DISCOMFORT. 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) 2017 DIAGNOSIS: PATELLAR CLUNK THERE WAS EXTENSIVE SCAR TISSUE AND AN EXTENSIVE DEBRIDEMENT WAS PERFORMED. THE PATIENT WAS TAKEN TO RECOVERY IN GOOD CONDITION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 17221901 ↗
• InjuryJun 26, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY REVISION ON (B)(6)2012 AND THEN APPROXIMATELY 10 YEARS 2 MONTHS LATER HAD A SURGICAL REVISION ON (B)(6)2022. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. REVISION OPERATIVE REPORT OF 17 NOV 2022- FOR FAILED RECALLED RIGHT TOTAL KNEE REPLACEMENT. INTRAOPERATIVE FINDINGS- LOOSE FEMORAL IMPLANTS, REMOVED EASILY WITH MODERATE BONE LOSS, REQUIRING TIBIAL CONDE DUE TO BONE LOSS. OSTEOLYSIS ALONG THE MEDIAL AND FEMORAL DISTAL CONDYLES. SIGNIFICANT POLYETHYLENE WEAR. INDICATION: PATIENT HAD SEVERE PAIN DUE TO FAILED RIGHT KNEE. PROCEDURE: THE FEMORAL IMPLANT WAS EASILY REMOVED DUE TO MINIMAL BONE INGROWTH. THE PATELLA BUTTON WAS WELL FIXED AND STABLE; IT WAS NOT REMOVED. NEW DEVICES WERE TRIALED AND THEN IMPLANTED. STERILE DRESSINGS WERE APPLIED; PATIENT SENT TO PACU IN STABLE CONDITION. NO COMPLICATIONS. HOSPITAL CARE: ADMITTED (B)(6)2022/DISCHARGED (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.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 17199682 ↗
• InjuryJun 26, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012 AND THEN APPROXIMATELY 10 YEARS, 1 MONTH LATER WAS REVISED ON (B)(6) 2022. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2022. PRELIMINARY DIAGNOSIS: SEVERE POLYETHYLENE WEAR, OSTEOLYSIS AND LOOSENING OF THE FEMORAL COMPONENT ASSOCIATED WITH LEFT TOTAL KNEE REPLACEMENT. INDICATION: PATIENT PRESENTED WITH LOOSENING AND OSTEOLYSIS. PROCEDURE: THE SYNOVIAL FLUID WAS CLEAR. A COMPLETE SYNOVECTOMY WAS PERFORMED. ON REMOVAL OF THE IMPLANTS, THE FEMORAL COMPONENT WAS LOOSE AT THE METAL CEMENT INTERFACE. THE TIBIAL COMPONENT WAS WELL FIXED WITH SUBSTANTIAL MEDIAL OSTEOLYSIS. THE PATELLAR COMPONENT WAS WELL FIXED WITH MINIMAL DAMAGE TO THE POLYETHYLENE BUTTON. THE POLYETHYLENE LINER SHOWED WEAR. THE STABILITY OF THE KNEE WAS ADEQUATE. IT WAS DECIDED TO REVISE THE FEMORAL AND TIBIAL COMPONENTS. A STERILE DRESSING WAS APPLIED, THE PATIENT WAS TRANSFERRED TO THE RECOVEREE AREA IN STABLE CONDITION. 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 ADD

  Patient problems: Osteolysis

  MAUDE report 17197494 ↗
• InjuryJun 12, 2023Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT KNEE TOTAL ARTHROPLASTY ON (B)(6) 2019, AND THEN HAD A REVISION PROCEDURE ON (B)(6) 2022; APPROXIMATELY 3 YEARS, 4 MONTHS, AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2022. POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO BEARING SURFACE WEAR. FINDINGS: THE PATIENT DID WELL FOR APPROXIMATELY 18 MONTHS AND THEN PRESENTED WITH RECURRENT SWELLING IN THE KNEE WITH SIGNS OF DRAMATIC SYNOVIAL EXPANSION WITH ACCUMULATION OF SYNOVIAL FLUID IN THE KNEE. THE KNEE WAS ALSO SOMEWHAT LAX WITH INCREASED LAXITY IN BOTH CORONAL AND SAGITTAL PLANES. RADIOGRAPHS SHOWED WELL-FIXED COMPONENTS. RADIOGRAPHS ALSO SHOWED WASHOUT OF THE CEMENT FROM UNDER THE MEDIAL TIBIAL PLATEAU. THERE WAS EXUBERANT FOREIGN BODY REACTION AND EXPANSION OF THE SYNOVIAL MEMBRANE. THERE WERE GROSSLY VISIBLE POLYETHYLENE PARTICLES IMBEDDED IN THE SOFT TISSUES OF THE KNEE. UNDER THE MEDIAL TIBIAL PLATEAU, THERE WAS OSTEOLYTIC REPLACEMENT OF THE CEMENT MANTLE. THE FEMORAL AND TIBIAL COMPONENTS REMAINED WELL FIXED AS DID THE PATELLAR COMPONENT, BUT THERE WAS AN AREA OF CEMENT WASHOUT UNDER THE MEDIAL TIBIAL PLATEAU.

  Patient problems: Balance Problems; Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 17106974 ↗
• InjuryMay 12, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD A KNEE REPLACEMENT ON (B)(6) 2018. THE PATIENT WAS SCHEDULED FOR REVISION SURGERY (B)(6) 2023, APPROXIMATELY 4 YEARS 5 MONTHS AFTER THEIR INITIAL PROCEDURE. THERE IS NO CONFIRMATION THE REVISION SURGERY HAS OCCURRED OR WHAT THE INDICATIONS WERE. 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; Insufficient Information; Pain

  MAUDE report 16919721 ↗
• InjuryApr 13, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE - (B)(4). RELATED CASE: (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT IS VERIFIED LEFT KNEE ON (B)(6) 2016 AND LEFT KNEE REVISION (B)(6) 2021. SHE HAD LEFT KNEE SECOND REVISION (B)(6) 2022, APPROXIMATELY 1 YEAR AND 4 MONTHS AFTER THEIR 1ST REVISION. POLY EXCHANGE. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO INSTABILITY AND POLYETHYLENE WEAR. 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. SERIAL #: (B)(4), CATEGORY #: 02-012-44-5011 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM, SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K110547. CONCOMITANTS: SERIAL #: (B)(4), CATEGORY #: CS-05CC - INTERSEP CALCIUM SULFATE, SERIAL #: (B)(4), CATEGORY #: 02-012-42-5008 - LOGIC PTS, SIZE 5, 8MM.

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

  MAUDE report 16735094 ↗
• InjuryApr 7, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - USA. PATIENT ID: (B)(6). IT WAS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2019 WITH NO COMPLICATIONS. ON (B)(6) 2022, APPROXIMATELY 3 YEARS 5 MONTHS FROM THE INITIAL, THE PATIENT RECEIVED A REVISED RIGHT KNEE REPLACEMENT DUE TO ¿THE PATIENT HAD MODERATE DEBRIS SYNOVITIS. IT WAS ACTUALLY NOT AS BAD AS THE PREVIOUS ARTHROSCOPY. THE FEMUR AND TIBIA WERE EVALUATED AND BOTH WERE INTACT WITHOUT ANY EVIDENCE OF LOOSENING." AN ARTHROSCOPY WAS PERFORMED ON (B)(6) 2022. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 510K: K110547.

  Patient problems: Failure of Implant; Synovitis

  MAUDE report 16701940 ↗
• InjuryMar 1, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL BILATERAL KNEE REPLACEMENT SURGERY ON (B)(6) 2017 WHERE HE WAS IMPLANTED WITH RECALLED OPTETRAK DEVICES. ON (B)(6) 2022, PLAINTIFF UNDERWENT LEFT TOTAL KNEE REVISION SURGERY DUE A ¿MECHANICAL LOOSENING OF INTERNAL LEFT KNEE PROSTHETIC JOINT¿, APPROXIMATELY 4 YEARS 11 MONTHS POST INITIAL PROCEDURE. HIS PHYSICIAN NOTED EVIDENCE OF POLYETHYLENE WEAR AND OSTEOLYSIS. PLAINTIFF¿S LEFT KNEE REVISION SURGERY WAS DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE DEFECTIVE POLYETHYLENE INSERT COMPONENT WITHIN THE OPTETRAK DEVICE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 16461486 ↗
• InjuryMar 1, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL BILATERAL KNEE REPLACEMENT SURGERY ON (B)(6) 2017 WHERE HE WAS IMPLANTED WITH RECALLED OPTETRAK DEVICES. PLAINTIFF¿S RIGHT KNEE IS CURRENTLY BEING MONITORED AND HE MAY ULTIMATELY REQUIRE REVISION SURGERY ON HIS RIGHT KNEE AS WELL. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Osteolysis; Pain

  MAUDE report 16461283 ↗
• InjuryFeb 28, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A PATIENT, WHO HAD AN INITIAL LEFT TKA, IMPLANTED WITH AN OPTETRAK POLYETHYLENE TIBIAL INSERT, ON (B)(6) 2016, EXPERIENCES PAIN IN HIS LEFT KNEE AND IT HAS BEEN RECOMMENDED THAT THE PLAINTIFF PROCEED WITH A REVISION SURGERY TO REMOVE THE RECALLED TIBIAL INSERT AT A LATER DATE. AS A DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICES AS DESCRIBED HEREIN, PLAINTIFF 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; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES WHICH ALL REQUIRE ONGOING MEDICAL CARE. AS A FURTHER DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICES, PLAINTIFF HAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; AND PAIN AND SUFFERING. NO FURTHER INFORMATION.

  Patient problems: Cyst(s); Extraskeletal ossification; Joint Laxity; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 16456622 ↗
• InjuryOct 27, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL TEAM, APPROXIMATELY TEN YEARS POST INITIAL BILATERAL TKA, THE MALE PATIENT HAD A REVISION OF HIS RIGHT KNEE FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Subluxation; Synovitis

  MAUDE report 15685964 ↗