Optetrak Logic 02-012-44-3009Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10885862173553), received between Aug 7, 2020 and Apr 21, 2026 — classified as 50 injuries.

The most frequently reported specific device problem is “Naturally Worn” (33 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 7 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT'S TIBIAL AND PATELLAR POLYS WERE REVISED DUE TO WEAR. BONE SCANS SHOWED HOT ACTIVITY ON THE POSTERIOR FEMUR, WHICH COULD INDICATE OSTEOLYSIS AND LOOSENING OF THE COMPONENT. INTRA-OP FINDINGS DEMONSTRATED A WELL-FIXED FEMUR, THEREFORE ONLY THE POLYS WERE REVISED. 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: Osteolysis

  MAUDE report 24944089 ↗
• InjuryOct 7, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (B)(4) RK REVISED IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 76 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN. 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: Insufficient Information

  MAUDE report 20388111 ↗
• InjuryOct 1, 2024Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  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 PROSTHESIS WEAR, BILATERAL KNEE PAIN, SWELLING, REDUCED FUNCTIONING, LOSS OF RANGE OF MOTION, GREAT PAIN AND ANGUISH; MECHANICAL FAILURE OF KNEE REPLACEMENT, REVISION SURGERY, INJURIES TO BONE AND TISSUE. 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; Failure of Implant; Implant Pain; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20344870 ↗
• InjurySep 24, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 90 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, CHRONIC LEFT HIP PAIN, LEFT HIP PAIN WITH AMBULATION, CYSTS. 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Pain; Scar Tissue

  MAUDE report 20295675 ↗
• InjurySep 24, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA: (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022 OR THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 20295635 ↗
• InjurySep 24, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 124 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, FRAGMENTATION OF PATELLA. 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: Bone Shedding Debris; Osteolysis; Scar Tissue

  MAUDE report 20295201 ↗
• InjuryAug 14, 2024Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 62 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY; PAIN AND DYSFUNCTION IMPACTED ACTIVITIES OF DAILY LIFE; SYNOVITIS; EXTENSIVE METALLOSIS; PSEUDOTUMOR; SCORIATION OF THE PATELLA WITH A LARGE LOOSE FLAP, CATASTROPHIC POLYETHYLENE WEAR OF THE TIBIAL INSERT; GROSSLY LOOSE FEMUR . 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; Bone Fracture(s); Failure of Implant; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19988005 ↗
• InjuryJun 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS, POLYETHYLENE WEAR, FEMORAL OSTEOLYSIS, AND FEMORAL LOOSENING. 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; Synovitis

  MAUDE report 19519022 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). PATIENT ID: DENISE CHAREST + LEFT KNEE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 111 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROTHESIS WEAR, POLYETHYLENE LINER WEAR, SYNOVITIS, ASEPTIC LOOSENING TIBIAL COMPONENT, AND FEMORAL COMPONENT LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Synovitis

  MAUDE report 19511569 ↗
• InjuryJun 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. EBI SURGERY DATA IS NOT AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19475350 ↗
• InjuryMar 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2021 APPROXIMATELY 7 YEARS AND 4 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; Synovitis

  MAUDE report 18815055 ↗
• InjuryOct 27, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THIS PATIENT HAD INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2014 AND THEN LATER EXPERIENCED RIGHT KNEE REVISION 9 YEARS, 1 MONTH LATER. PATIENT REVISED TO COMPETITOR¿S DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2023- PRE-OP DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT. PROCEDURE: 1) REVISION RIGHT TOTAL KNEE ARTHROPLASTY (TIBIAL AND FEMORAL IMPLANTS). PATIENT IS MORBIDLY OBESE WITH A BMI OF 44; THIS REQUIRED ADDITIONAL OPERATIVE TIME. INTRAOPERATIVE FINDINGS: LOOSE FEMORAL AND TIBIAL IMPLANTS - REMOVED EASILY WITH SEVERE BONE LOSS - REQUIRED FEMORAL AND TIBIAL CONES. THE LATERAL FEMORAL CONDYLE BONE LOSS WAS SEVERE - AN AREA OF BONE ALONG THE DISTAL FEMORAL CONDYLE THE SIZE OF A PING-PONG BALL WAS DESTROYED AS A RESULT OF POLYETHYLENE WEAR. THIS APPEARED TO BE OSTEOLYSIS. THIS REQUIRED A CONE FOR FIXATION AS WELL AS A CCK LOCKING LINER. THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE KNEE JOINT CONSISTENT WITH A SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUES. THIS WAS TINY, SMALL BALLS OF LIGHT BROWN / WHITE SYNOVIUM ALONG WITH A "PSEUDO-CAPSULE" OF DENSE SOFT TISSUE RIND. THE TOTAL AMOUNT OF SOFT TISSUE DAMAGE THAT REQUIRED RESEC

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

  MAUDE report 18022964 ↗
• InjuryOct 26, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT 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 LEFT KNEE, ASEPTIC LOOSENING OF FEMORAL COMPONENT, OSTEOLYSIS THERE WAS EXTENSIVE SYNOVITIS AND A VERY THOROUGH SYNOVECTOMY OF THE JOINT WAS PERFORMED. THE POLYETHYLENE LINER WAS REMOVED. THERE WAS NOTED TO BE WEAR OF THE LINER MEDIAL AND AROUND THE POST. NEXT THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND IT WAS REMOVED. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH MARKED OSTEOLYSIS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 18012717 ↗
• InjurySep 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2015. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON ((B)(6) 2023, APPROXIMATELY 8 YEARS 1 MONTH POST PRIMARY PROCEDURE. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: LEFT KNEE POLYETHYLENE-ASSOCIATED SYNOVITIS. THE SURGEON NOTED THERE WAS EXTENSIVE PROLIFERATIVE SYNOVITIS IN THE MEDIAL GUTTER AND AROUND THE SUPRAPATELLAR POUCH. THE POLYETHYLENE INSERT SHOWED SOME EVIDENCE OF POSTEROMEDIAL WEAR. THE FEMORAL AND TIBIAL COMPONENTS DID NOT DEMONSTRATE ANY INSTABILITY INTRA-OPERATIVELY. 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: Discomfort; Failure of Implant; Synovitis

  MAUDE report 17735738 ↗
• InjuryAug 30, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  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 3 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2023 OP REPORT POSTOPERATIVE DIAGNOSIS: MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHETIC JOINT. THE PATIENT PRESENTED WITH RIGHT KNEE PAIN AND EFFUSION WITH POLYETHYLENE WEAR AND OSTEOLYSIS ON IMAGING. UPON REMOVAL, THE SURGEON NOTED THE POLYETHYLENE INSERT HAD SIGNIFICANT WEAR ON THE MEDIAL GREATER THAN LATERAL ARTICULAR SURFACE. THERE WERE SOME FREE SHEERED OFF PIECES OF POLYETHYLENE WITHIN THE JOINT AS WELL. THE FEMORAL COMPONENT WAS FOUND TO BE SIGNIFICANTLY LOOSE AND WAS EASILY REMOVED. THERE WAS NO CEMENT THAT REMAINED ON THE BACKSIDE OF THE IMPLANT. REMOVAL OF THE FEMORAL COMPONENT REVEALED AORI 2B BONE LOSS FROM AREAS OF SIGNIFICANT OSTEOLYSIS, MOST NOTABLE AT THE POSTERIOR LATERAL CONDYLE. THE TIBIAL COMPONENT WAS FOUND TO HAVE SIGNIFICANT OSTEOLYSIS UNDERNEATH THE TRAY ON THE MEDIAL SIDE. WHILE DRILLING FOR THE BOSS OF THE TIBIA, THERE WAS NOTED TO BE A BREACH OF THE POSTERIOR CORTEX OF THE TIBIA. THE PATELLA WAS ALSO NOTED TO BE LOOSE.

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

  MAUDE report 17650228 ↗
• InjuryApr 24, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A 50 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022, APPROXIMATELY 6 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS SEEN IN THE OFFICE WITH A FAILED LEFT TOTAL KNEE REPLACEMENT REFRACTORY TO CONSERVATIVE MANAGEMENT. IMAGING WAS CONSISTENT WITH FAILED LEFT KNEE ARTHROPLASTY. THE PATIENT WAS INDICATED FOR SURGERY. INFORMED CONSENT WAS OBTAINED BY THE PATIENT WHO UNDERSTOOD THE RISKS AND BENEFITS OF THE PROCEDURE AND WISHED TO PROCEED. IMPLANTS WERE REMOVED. THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND WAS REMOVED BY HAND. ATTENTION TURNED TO THE TIBIA. THE TIBIA WAS REMOVED WITH MINIMAL BONE LOSS. THE PATIENT WAS RE-IMPLANTED WITH A COMPETITOR¿S DEVICES. A CONDYLAR CONSTRAINED TOTAL KNEE PROSTHESIS WITH STEMS ON THE FEMORAL AND TIBIAL COMPONENTS WERE INSERTED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PRE-OP AND POST-OP DIAGNOSIS INDICATED MECHANICAL LOOSENING OF THE INTERNAL LEFT KNEE PROSTHETIC JOINT. PRIMARY DEVICE REPORTED IS THE POLY LINER. FEMUR DEVICE INFORMATION IS UNKNOWN. NO DEVICE RETURNS ANTICIPATED

  Patient problems: Insufficient Information

  MAUDE report 16801773 ↗
• InjuryApr 10, 2023Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - (B)(6). PER INFORMATION RECEIVED BY THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 6 YEARS AND 9 MONTHS AFTER FIRST REPLACE THE PATIENT HAD A REVISION ON (B)(6) 2022. SEVERE POLY WEAR ALONG THE MEDIAL AND LATERAL SURFACE WITH A BROKEN PORTION OF THE PS POST TIP AS WELL. GROSSLY LOOSE FEMORAL AND TIBIAL IMPLANTS - REMOVED EASILY WITH MINIMAL BONE LOSS. MASSIVE DISTAL FEMORAL MEDIAL AND LATERAL CONDYLE BONE LOSS - MEDIAL CONDYLE WAS SO DAMAGED THERE WAS A FRACTURE PRESENT THAT REQUIRED TWO SCREW FIXATION. REVISED TO ZIMMER. PATIENT SENT TO PACU IN STABLE CONDITION. SERIAL #:(B)(4), CATEGORY #: 02-012-44-3009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM, SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. RECALL: Z-0021-2022. 510K: K110547. CONCOMITANTS: SERIAL #: (B)(4), CATEGORY #: 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3; SERIAL #: (B)(4), CATEGORY #: 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T; SERIAL #: (B)(4), CATEGORY #: 200-02-32 - THREE PEG PATELLA 32MM.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 16708191 ↗
• InjuryMar 22, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE MALE PATIENT HAD AN INITIAL TKA ON (B)(6) 2017 . THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK LOGIC PS POLYETHYLENE TIBIAL INSERT. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Erosion; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16595625 ↗
• InjuryMar 8, 2023Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2014 AND WAS IMPLANTED WITH AN OPTETRAK LOGIC PSC POLYETHYLENE TIBIAL INSERT. PLAINTIFF HAS BEEN RECOMMENDED TO UNDERGO LEFT KNEE REVISION SURGERY IN THE SPRING OF 2023 DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK LOGIC PSC POLYETHYLENE TIBIAL INSERT. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Erosion; Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16501834 ↗
• InjuryMar 1, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY LEGAL, APPROXIMATELY 2 YEARS POST OP THE INITIAL LEFT TKA, THIS MALE PATIENT WAS REVISED DUE TO THE OPTETRAK DEVICE FAILING.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16461291 ↗
• InjuryMar 1, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS POST OP THE INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE DEFECTIVE POLYETHYLENE INSERT COMPONENT WITHIN THE OPTETRAK DEVICE.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Extraskeletal ossification; Failure of Implant; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 16458951 ↗
• InjuryMar 1, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY LEGAL, APPROXIMATELY 8 YEARS POST OP THE INITIAL LEFT TKA, THIS MALE PATIENT WAS REVISED DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE DEFECTIVE POLYETHYLENE INSERT COMPONENT WITHIN THE OPTETRAK DEVICE.

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

  MAUDE report 16458924 ↗
• InjuryFeb 28, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A PATIENT, WHO HAD AN INITIAL RIGHT TOTAL KNEE REPLACEMENT, AND WAS IMPLANTED WITH OPTETRAK DEVICES, INCLUDING OPTETRAK LOGIC TIBIAL INSERTS MADE OF POLYETHYLENE IN (B)(6) 2013, UNDERWENT A REVISION PROCEDURE IN 2016, FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. THE (B)(6) 2013 ARTHROPLASTY WAS DONE CORRECTLY AND DID NOT DEVIATE FROM ACCEPTED MEDICAL CUSTOM AND PRACTICE WITH REGARDS TO THE IMPLANTATION OF THE OPTETRAK DEVICE. IN OR AROUND (B)(6) OF 2022, THE PLAINTIFF WAS ADVISED THAT HER KNEE REPLACEMENT FAILED FOR REASONS RELATED TO THE DEFECTIVE DEVICE. THE PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HER KNEE WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Insufficient Information; Joint Laxity; Pain

  MAUDE report 16454533 ↗
• InjuryFeb 27, 2023Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF. ON OR ABOUT (B)(6) 2015, PATIENT UNDERWENT RIGHT KNEE REPLACEMENT AND WAS IMPLANTED WITH AN EXACTECH OPTETRAK LOGIC COMPREHENSIVE TOTAL KNEE REPLACEMENT. ON OR ABOUT (B)(6) 2022, PATIENT UNDERWENT A REVISION SURGERY ON HER RIGHT KNEE FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. THE REVISION OPERATIVE REPORT FOR THIS SURGERY NOTED ¿A SIGNIFICANT DEGREE OF REACTIVE SYNOVITIS AND METAL STAINING OF THE SYNOVIUM CONSISTENT WITH POLYETHYLENE WEAR AND OSTEOLYSIS,¿ AMONG OTHER ISSUES.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16444997 ↗
• InjuryFeb 16, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY NINE YEARS POST INITIAL LEFT SIDE TKA, THE 63 Y/O FEMALE PATIENT WAS BROUGHT BACK FOR LEFT KNEE INSTABILITY. PATIENT WAD REVISED TO A TRULIANT SIZE 3 15MM PSC INSERT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS RECEIVED. THE DEVICE WILL BE RETURN. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16386539 ↗