Optetrak Logic 02-012-35-4015Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10885862001917), received between Nov 2, 2020 and Feb 11, 2025 — classified as 24 injuries.

The most frequently reported specific device problem is “Naturally Worn” (19 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K033883); 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  APPROXIMATELY 9 YEAR(S), 11 MONTH(S) AND 12 DAY(S) POST-OPERATIVE OF A LEFT TKA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED POLYETHYLENE WEAR WITHOUT EVIDENCE OF OSTEOLYSIS. CLINIC NOTE STATED MILD MEDIOLATERAL LAXITY, MILD EFFUSION WITH PERHAPS A TOUCH OF MEDIAL POLY WEAR. THE PATIENT IS BEING MONITORED AND IS TO BE REVIEWED IN 2 YEARS¿ TIME, EARLIER, IF NECESSARY, WITH X-RAY ON ARRIVAL. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING, AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Laxity; Joint effusion

  MAUDE report 21356723 ↗
• InjuryFeb 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 62 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2013, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 11 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THE SURGEON REVISED THE PATIENT¿S LOGIC FEMORAL COMPONENT, TIBIAL INSERT AND PATELLA DUE TO OSTEOLYSIS. THERE WAS SIGNIFICANT POLYETHYLENE WEAR ON THE TIBIAL INSERT AND PATELLA. THERE WAS NO CEMENT ADHERED TO THE LOGIC FEMORAL COMPONENT ONCE IT WAS REMOVED. CEMENT WAS ONLY PRESENT ON THE FEMUR. THE SURGEON LEFT THE LOGIC TIBIAL COMPONENTS IN PLACE AS THEY WERE WELL FIXED. HE REVISED THE FEMUR TO LOGIC CC COMPONENTS AND REPLACED THE PATELLA WITH AN ACTIVE E TRULIANT 3 PEG PATELLA. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THE FACILITY HELD THE PRODUCT. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 21315620 ↗
• InjuryJan 28, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 10 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Pain

  MAUDE report 21254242 ↗
• InjuryJan 10, 2025Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT, WHO HAD AN INITIAL KNEE IMPLANTED IN (B)(6) 2020, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 4 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. PAIN, JOINT EFFUSION AND PROSTHETIC INSTABILITY WITH RADIOLOGICAL FINDINGS OF OSTEOLYSIS IN RELATION TO THE TIBIAL AND FEMORAL COMPONENTS, PET WEAR AND OTHER TESTS WITH A DIAGNOSIS OF ASEPTIC LOOSENING OF THE KNEE PROSTHESIS. ELEVATED LEVELS OF METALS (CHROMIUM AND COBALT) IN THE BLOOD. PROSTHESIS AFFECTED BY HEALTH ALERT FOR ITS WITHDRAWAL FROM THE MARKET. SIGNIFICANT DISABILITY. NEED FOR SURGICAL INTERVENTION TO AVOID INJURY OR PERMANENT DISABILITY. THREAT TO LIFE. X-RAY IMAGES WERE PROVIDED. NO DEVICE IMAGES WERE PROVIDED.

  Patient problems: Deformity/ Disfigurement; Joint Laxity; Joint effusion; Osteolysis; Pain

  MAUDE report 21124674 ↗
• InjuryOct 28, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. (B)(6)). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 90 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INCREASING PAIN, SWELLING, AND INSTABILITY; REVISION SURGERY; BONY DEFECTS ON FEMUR AND TIBIA; LENGTHY AND PAINFUL RECOVERY. 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; Joint Laxity; No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20551361 ↗
• InjuryAug 13, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE - (B)(4). IT WAS REPORTED THAT APPROXIMATELY 161 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Cyst(s); Failure of Implant; Joint Laxity; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 19976989 ↗
• InjuryJun 24, 2024Fracture; Unstable; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Unstable; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION 10JUN2024, PATIENT IS VERIFIED FOR LTKA (B)(6) 2013. PATIENT HAD LEFT KNEE REVISION ON (B)(6) 2024 (OP REPORT ATTACHED). PREOPERATIVE DIAGNOSIS: 1. MECHANICAL LOOSENING OF INTERNAL LEFT KNEE PROSTHETIC JOINT, INITIAL ENCOUNTER, LEFT. 2. POLYETHYLENE WEAR LEFT TOTAL KNEE ARTHROPLASTY WITH RECALLED IMPLANT. 3. SEVERE OSTEOLYSIS LEFT DISTAL FEMUR, AS WELL AS OSTEOLYSIS OF TIBIA AND PATELLA. 4. PRIOR TIBIAL SHAFT VALGUS MALUNION. POSTOPERATIVE DIAGNOSIS: SAME. PROCEDURES PERFORMED: 1. REVISION LEFT TKA OF ALL COMPONENTS WITH COMPUTER ASSISTED NAVIGATION. 2. APPLICATION OF BONE VOID FILLER TO LEFT DISTAL FEMUR. 3. APPLICATION OF NEGATIVE PRESSURE WOUND VACUUM DRESSING. OPERATIVE FINDINGS: GROSS LOOSENING OF LTKA, SEVERE POLYETHYLENE WEAR AND DELAMINATION OF POLYETHYLENE OF TIBIA AND PATELLA, SEVER OSTEOLYSIS OF FEMUR, TIBIA AND PATELLA. INCOMPETENCE OF MEDIAL COLLATERAL LIGAMENT DUE TO ECSTATIC MEDIAL EPICONDYLE, GROSS INSTABILITY, PRIOR TIBIAL SHAFT MALUNION WITH VALGUS ALIGNMENT. CLINICAL HISTORY: PATIENT IS 64 Y.O. MALE STATUS POST LTKA REPLACEMENT IN 2013 WITH A RECALLED EXACTECH TKA NOW PRESENTING WITH WORSENING KNEE PAIN EFFUSION AND IMAGING SUG

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Joint Laxity; Joint effusion; Osteolysis

  MAUDE report 19593110 ↗
• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 88 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.

  Patient problems: Insufficient Information

  MAUDE report 19313108 ↗
• InjuryApr 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, WITH UNREVISED SCHEDULED REVISION DATE ON (B)(6) 2024. THERE IS NO DEVICE INFORMATION PROVIDED. 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: Failure of Implant; Insufficient Information

  MAUDE report 19085971 ↗
• InjuryFeb 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2009, APPROXIMATELY 34 DAYS AFTER INITIAL IMPLANT. 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; Unspecified Infection

  MAUDE report 18716497 ↗
• InjuryAug 25, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2015 DUE TO SEVERE OSTEOARTHRITIS. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 7 YEARS POST PRIMARY PROCEDURE. REVISION OP REPORT NOTED THAT A FRAGMENTED PIECE OF PATELLAR BONE WAS PRESENT LATERALLY WHICH WAS MOBILE AND DISCONTINUOUS RELATIVE TO THE EXTENSOR MECHANISM. OSTEOLYSIS WAS NOTED PARTICULARLY INVOLVING THE ANTERIOR FEMUR AND LATERAL FEMORAL CONDYLE, AND INVOLVING MAINLY THE MEDIAL TIBIAL PLATEAU. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Discomfort; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 17624445 ↗
• InjuryJul 5, 2023Naturally Worn; Patient Device Interaction Problem; Naturally Worn; Patient Device Interaction Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON 7 AUG 2015 AND THEN APPROXIMATELY 7 YEARS, 5 MONTHS LATER THEY HAD A REVISION SURGICAL PROCEDURE ON (B)(6) 2023. REVISION OPERATIVE REPORT OF (B)(6) 2023 -FAILED LEFT TOTAL KNEE ARTHROPLASTY. PATIENT REVISED TO COMPETITOR¿S DEVICES. INDICATION: PATIENT WAS SEEN IN THE OFFICE WITH A FAILED LEFT KNEE REFRACTORY TO CONSERVATIVE MANAGEMENTS. IMAGING WAS CONSISTENT WITH FAILED LEFT KNEE ARTHROPLASTY. PROCEDURE: A THOROUGH SYNOVECTOMY WAS PREFORMED, AND CULTURES WERE SENT. IMPLANT REMOVAL-FEMORAL REMOVED, TYPE F3 BONE LOSS WAS PRESENT WITH SIGNIFICANT EROSION OF BOTH MEDIAL AND LATERAL CONDYLES, COMPRISING COLLATERAL STABILITY. TIBIA, REMOVED, TYPE T3 BONE LOSS WAS PRESENT WITH COMPLETE VIOLATION OF THE LATERAL AND ANTEROLATERAL TIBIAL CORTEX. TRIALS WERE CONDUCTED, NEW DEVICES WERE IMPLANTED. DRESSINGS WERE APPLIED, THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM 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 ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17262000 ↗
• InjuryApr 25, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PER A REPORT FROM THE LEGAL DEPARTMENT A 64 Y/O MALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION 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. REVISION OP REPORT - (B)(6) 2022. POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE POLYETHYLENE DUE TO RECALL WITH LOOSE FEMORAL COMPONENT. THERE WAS VISIBLE EVIDENCE OF POLYETHYLENE WEAR AND A PARTIALLY LOOSE TIBIAL COMPONENT. SEVERE AMOUNT OF OSTEOLYSIS WAS FOUND AROUND THE DISTAL FEMUR AND PROXIMAL TIBIA. THERE WAS A SEVERE SYNOVIAL REACTION THROUGHOUT THE ENTIRE KNEE AND A COMPLETE SYNOVECTOMY WAS PERFORMED. X-RAYS SHOWED FEMORAL LOOSENING AND OSTEOLYSIS. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION WITH NO COMPLICATIONS.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 16808265 ↗
• InjuryFeb 22, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT THE MALE PATIENT HAD A RIGHT KNEE IMPLANTED (B)(6) 2013 AND UNDERWENT REVISION SURGERY ON (B)(6) 2022 TO REMOVE THE FAILED POLYETHYLENE LINER DUE TO MECHANICAL COMPLICATION OF PROSTHETIC KNEE IMPLANT. PATHOLOGY FINDINGS FROM THE REVISION SURGERY INCLUDED ¿A MONONUCLEAR AND FOREIGN BODY GIANT CELL REACTION TO POLYETHYLENE SHARDS WHICH EXPANDS THE SUBSYNOVIUM. 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 WHICH ALL REQUIRE ONGOING MEDICAL CARE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Foreign Body Reaction; Pain; Scar Tissue

  MAUDE report 16417951 ↗
• InjuryFeb 14, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2013, PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT SURGERIES. DURING THE SURGERY, PATIENT'S SURGEON REPLACED BOTH KNEES WITH OPTETRAK LOGIC KNEES, INCLUDING OPTETRAK LOGIC TIBIAL INSERTS. IN (B)(6) 2022, AFTER EXPERIENCING KNEE AND LEG PAIN THAT NECESSITATED FREQUENT REST, ICE, AND USE OF A CANE, PATIENT RECEIVED A LETTER FROM HER SURGEON ADVISING HER THAT HER EXACTECH KNEE REPLACEMENTS HAD BEEN RECALLED. IN (B)(6) 2022, PATIENT'S RIGHT KNEE PAIN BECAME CONSIDERABLY WORSE, AS SHE WAS UNABLE TO TAKE MORE THAN A COUPLE OF STEPS WITHOUT SHARP, SHOOTING PAIN. SHE REQUIRED A WALKER TO TAKE EVEN A FEW SHORT STEPS. PATIENT¿S PAIN PROGRESSED TO WHERE SHE WAS NO LONGER ABLE TO DRIVE, DO TASKS AROUND THE HOUSE, OR WORK AT THE BUSINESS SHE OWNS. INDEED, PATIENT¿S FAMILY HIRED CAREGIVERS HAD TO PROVIDE ROUND THE CLOCK CARE. PATIENT CONSULTED WITH AN ORTHOPEDIC SURGEON IN (B)(6) 2022. X-RAYS PERFORMED AS A PART OF PATIENT¿S EVALUATION OF HER RIGHT KNEE REVEALED A LARGE AREA OF BONE LOSS (OSTEOLYSIS) UNDERNEATH THE TIBIAL TRAY OF HER OPTETRAK LOGIC KNEE AND POTENTIAL OSTEOLYSIS IN THE FEMUR AS WELL. GIVEN HER PAIN AND THE SURGEON¿S FINDINGS, PATIEN

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 16373081 ↗
• InjuryNov 28, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL THAT A PATIENT WITH BILATERAL KNEE REPLACEMENT STATES THAT, "THE RIGHT KNEE WAS REPLACED FIRST AND THIS ONE FAILED." THE PATIENT HAS PAIN AND "SUFFERING." "THE DOCTOR WANTS ME BACK ANNUALLY TO WATCH THE OTHER KNEE WHICH WAS DONE LAST YEAR WITH THE SAME PRODUCT BUT TO DATE SHOWS NO ISSUES."

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

  MAUDE report 15870208 ↗
• InjuryAug 5, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL FILING THAT A MALE PATIENT, WHO WAS INITIALLY IMPLANTED ON (B)(6) 2015 ON HIS LEFT KNEE WITH AN OPTETRAK TKA SYSTEM, INDICATED THE TKA SYSTEM HAD FAILED IN (B)(6) 2016 AND UNDERWENT REVISION SURGERY APPROXIMATELY 1 YEAR 3 MONTHS POST THE INITIAL IMPLANT PROCEDURE. THEY REMOVED THE IMPLANT AND REPLACED IT WITH ANOTHER JOINT REPLACEMENT SYSTEM.

  Patient problems: Insufficient Information; Medical device site infection; Pain; Synovitis

  MAUDE report 15179686 ↗
• InjuryMay 18, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TKA, THIS PATIENT IS PRESENTING WITH OSTEOLYSIS ON THE MEDIAL FEMORAL EPICONDYLE WHICH IS CURRENTLY ASYMPTOMATIC BUT SURGEON BELIEVES IT¿S DUE TO POLY WEAR. AT THE MOMENT THE PATIENT IS CONSIDERING THEIR OPTIONS BUT SURGEON ANTICIPATES THE POLY EXCHANGE WILL OCCUR WITHIN THE NEXT THREE MONTHS. X-RAY RECEIVED. NO OTHER INFORMATION PROVIDED.

  Patient problems: Osteolysis

  MAUDE report 14427287 ↗
• InjuryFeb 4, 2022Fracture; Fracture

  AS REPORTED, APPROXIMATELY 9.91 YEARS SINCE INITIAL IMPLANT, THIS FEMALE PATIENT WITH BMI 32.1 UNDERWENT A RIGHT SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL # (B)(4). ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION DUE TO A PERIPROSTHETIC FRACTURE. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

  Patient problems: Bone Fracture(s)

  MAUDE report 13453243 ↗
• InjuryFeb 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 10.09 YEARS SINCE INITIAL IMPLANT, THIS MALE PATIENT WITH BMI 22.7 UNDERWENT A LEFT SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL # (B)(4). ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

  Patient problems: Failure of Implant

  MAUDE report 13450393 ↗
• InjuryNov 22, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YR POSTOP THE INITIAL TKA, THIS MALE PATIENT HAD A REVISION DUE TO POLY WEAR. NO ADDITIONAL INFORMATION AVAILABLE. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12858322 ↗
• InjuryDec 15, 2020Degraded; Degraded

  IT WAS REPORTED THAT A (B)(6) PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6)2018, DUE TO PROSTHESIS WEAR AND OSTEOLYSIS. PROSTHESIS WEAR AND OSTEOLYSIS ARE KNOWN DEVICE SPECIFIC RISKS. INITIAL SURGERY DATE WAS (B)(6) 2013. THIS PATIENT HAD BILATERAL KNEE SURGERY. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Osteolysis

  MAUDE report 11009341 ↗
• InjuryDec 15, 2020Degraded; Degraded

  IT WAS REPORTED THAT A (B)(6) PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2018, DUE TO POLY EXCHANGE. INITIAL SURGERY DATE WAS (B)(6) 2013. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11009309 ↗
• InjuryNov 2, 2020Unstable; Unstable

  IT WAS REPORTED THAT A (B)(6) PATIENT AT (B)(6) KG EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2013, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2011. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10775751 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants