Optetrak Logic 02-010-01-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10885862001160), received between Jul 26, 2019 and May 20, 2026 — classified as 60 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (49 reports).

3 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  REPORT # 2 OF 2 FOR THIS EVENT. IT WAS REPORTED A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, SIX (6) YEARS LATER, A BONE SCAN REVEALED POLYMERIC-INDUCED SYNOVITIS AND CIRCUMFERENTIAL BONE RESORPTION OVER THE PATELLA. DUE TO WORSENING PAIN AND INSTABILITY, FIVE (5) MONTHS POST THE BONE SCAN, THE PATIENT UNDERWENT LEFT KNEE REVISION. REVISION NOTES FROM THE SURGEON NOTED THE PATIENT PRESENTED WITH FAILURE OF THE TOTAL KNEE REPLACEMENT. THERE WAS EXUBERANT SYNOVITIS THROUGHOUT THE ENTIRETY OF THE KNEE JOINT. SYNOVITIS WAS CONSISTENT WITH SIGNIFICANT POLYETHYLENE WEAR DISEASE AND LOOSENING OF THE FEMORAL COMPONENT. A LARGE CYSTIC PROBABLY INDUCED CAVITY WAS FOUND IN THE LATERAL FEMORAL CONDYLE. THE TIBIAL TRAY HAD NO EVIDENCE OF LOOSENING. THE PATIENT WAS REVISED TO A DIFFERENT MANUFACTURE'S KNEE SYSTEM. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 25234569 ↗
• InjuryApr 14, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, BONE SCANS SUGGESTED LOOSENING, NO SIGNS OF INFECTION. AS A RESULT, APPROXIMATELY TWO YEARS AND SEVEN MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. THE REVISION OPERATIVE REPORT STATED, THERE WAS A ¿LITTLE BIT OF OVERGROWTH OF SOFT TISSUE OVER THE PATELLA, BUT OTHERWISE IN GOOD CONDITION¿THERE WERE NO SIGNS OF INFECTION¿ WE THEN BEGAN TO LOOK AT THE IMPLANTS AND PROBING AROUND THE FEMUR. THE BONE WAS EXTREMELY SOFT ON THE LATERAL ASPECT WHERE HE WAS 17 AND AFTER FURTHER INVESTIGATION FOUND THAT THERE WAS SOME LOOSENING ON THIS FEMORAL IMPLANT.¿ THE PATIENT¿S POSTOPERATIVE DIAGNOSIS WAS ¿LOOSENING OF TIBIAL AND FEMORAL COMPONENTS DUE TO OSTEOPENIC BONE.¿ WEAR WAS NOT REPORTED FOR THE TIBIAL INSERT IN THE OPERATIVE REPORT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Aseptic loosening; Osteopenia/ Osteoporosis; Pain

  MAUDE report 24873538 ↗
• InjuryNov 24, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 161 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT WAS REVISED. THEY EXPERIENCED PROSTHESIS WEAR AND SYNOVITIS. ADDITIONALLY REPORTED THERE WAS FEMORAL KNEE DEBONDING/LOOSENING AND ACUTE PAIN OF THEIR LEFT KNEE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS 1 OF 3 REPORTS.

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

  MAUDE report 23640687 ↗
• InjuryNov 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO MECHANICAL LOOSENING OF THE INTERNAL LEFT KNEE PROSTHETIC JOINT. THERE WERE NO MARKINGS ON THE OPTETRAK LOGIC PS TIBIAL INSERT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23610601 ↗
• InjuryNov 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT HAD PAIN AND FEMORAL DEBONDING/LOOSENING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23598126 ↗
• InjuryNov 19, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, INSTABILITY AND DEBONDING OF THE FEMORAL COMPONENT. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 12 YEARS AND 9 MONTHS AFTER INITIAL IMPLANTATION. 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; Osteolysis

  MAUDE report 23594958 ↗
• InjuryJun 19, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. FIVE YEARS LATER, RADIOGRAPHS SHOWED POLYETHYLENE ASYMMETRY. THE PATIENT REPORTED KNEE DISCOMFORT. OSTEOLYSIS WAS OBSERVED IN THE FEMUR, AFFECTING THE ANTERIOR FLANGE AND THE CONDYLES. TWO YEARS LATER, IMAGING (CAT SCAN AND BONE SCINTIGRAPHY) REVEALED OSTEOLYSIS, INSTABILITY, AND FEMORAL COMPONENT LOOSENING. TWO YEARS LATER, REVISION SURGERY WAS PERFORMED USING COMPETITOR SLEEVES. NO RELEVANT MEDICAL HISTORY PROVIDED.

  Patient problems: Discomfort; Joint Laxity; Osteolysis

  MAUDE report 22289619 ↗
• InjuryApr 1, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6.72 YEARS SINCE INITIAL IMPLANT, THIS MALE PATIENT WITH BMI 36.3 UNDERWENT A LEFT SIDE TOTAL KNEE REPLACEMENT. THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

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

  MAUDE report 21743205 ↗
• InjuryMar 10, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT, APPROXIMATELY 86 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, LOOSENING OF THE FEMORAL COMPONENT, INSTABILITY, OSTEOLYSIS, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21559126 ↗
• InjuryFeb 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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. THIS IS REPORT 3 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 21315904 ↗
• InjuryJan 29, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; 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 21270405 ↗
• InjuryJan 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 85 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FEMORAL LOOSENING, UNSPECIFIED MENTAL, EMOTIONAL OR BEHAVIOURAL PROBLEM AND PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 21264558 ↗
• InjuryJan 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 85 MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, CYST, JOINT EFFUSION, JOINT LAXITY, OSTEOLYSIS, PAIN, SWELLING/EDEMA, AND SYNOVITIS. 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: Cyst(s); Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21210680 ↗
• InjuryJan 8, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 116 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND INSTABILITY. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED LEFT TOTAL KNEE FAILURE ASEPTIC. INTRAOPERATIVELY IT WAS NOTED THAT A COMPLEX SCAR REVISION WAS NECESSARY. IT WAS NOTED THAT THE FEMUR WAS DEBONDING FROM THE CEMENT. POSTERIOR OSTEOPHYTES WERE REMOVED. INTRAOPERATIVE X-RAYS WERE TAKEN AND REVIEWED PRIOR TO COMPLETION OF THE OPERATION, AND IT WAS NOTED THAT NO FRACTURES WERE SEEN, AND ALL IMPLANTS WERE IN ACCEPTABLE POSITION. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint Laxity; Scar Tissue

  MAUDE report 21101851 ↗
• InjuryJan 7, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - LK REV IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 AND THEN APPROXIMATELY 5 YEARS, 5 MONTHS LATER WAS REVISED ON (B)(6) 2022. PATIENT CLAIMS REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, INSTABILITY, OSTEOLYSIS, AND COMPONENT LOOSENING. 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. THERE IS NO OPTETRAK DEVICE SPECIFIC INFORMATION PROVIDED. THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. EBI INITIAL SURGERY COULD NOT BE FOUND. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS.

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

  MAUDE report 21095565 ↗
• InjuryJan 6, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 139 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, FAILURE OF IMPLANT, IMPLANT PAIN, JOINT EFFUSION, JOINT LAXITY, OSTEOLYSIS, AND SYNOVITIS. INITIAL SURGERY AND 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 21078633 ↗
• InjuryDec 30, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 62 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, SWELLING, EFFUSION, AND DECREASED RANGE OF MOTION. POST OPERATIVE DIAGNOSIS NOTED SIGNIFICANT POLYETHYLENE WEAR AND LOOSENING OF THE FEMORAL COMPONENT. INTRAOPERATIVELY, THE SURGEON OBSERVED SIGNIFICANT GRANULATION TISSUE CONSISTENT WITH POLYETHYLENE WEAR AND THE TIBIAL INSERT WAS SIGNIFICANTLY WORN BOTH MEDIALLY AND LATERALLY WITH DELAMINATION BUT NOTED AS WELL FIXED. THE FEMORAL COMPONENT WAS NOTED AS LOOSE WITH A WELL-FIXED CEMENT MANTLE AND EASILY REMOVED WITHOUT SIGNIFICANT BONE LOSS.

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

  MAUDE report 21036760 ↗
• InjuryDec 30, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; 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 LOOSENING, FAILURE OF IMPLANT, IMPLANT PAIN, JOINT EFFUSION, JOINT LAXITY, OSTEOLYSIS, AND SYNOVITIS. 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: Aseptic loosening; Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21034437 ↗
• InjuryDec 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 10 YEARS 11 MONTHS POST PRIMARY PROCEDURE. THE PATIENT EXPERIENCED OSTEOLYSIS AND SYNOVITIS. 27 MAR 2023 OP REPORT FINDINGS: DEBONDING OF THE LEFT KNEE FEMORAL COMPONENT; SIGNIFICANT POLYETHYLENE WEAR. PREOPERATIVE X-RAYS SHOWED POLYETHYLENE WEAR. SURGEON NOTED THERE WAS RICE BODY TYPE SYNOVITIS THROUGHOUT THE ENTIRETY OF THE SYNOVIAL TISSUE. THE FEMORAL COMPONENT HAD COMPLETELY DEBONDED AND WITH NO BONE LOSS THE IMPLANT COMPLETELY SEPARATED FROM THE CEMENT MANTLE. PATIENT TOLERATE PROCEDURE WELL WITH NO INTRAOPERATIVE COMPLICATIONS NOTED. 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: Osteolysis; Synovitis

  MAUDE report 21028917 ↗
• InjuryDec 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THE PATIENT EXPERIENCED PROSTHESIS WEAR, LOOSENING, SCAR TISSUE, OSTEOLYSIS, IMPLANT PAIN AND FAILURE OF IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED LEFT TOTAL KNEE THERE WAS EXTENSIVE ARTHROFIBROSIS AND OSTEOLYTIC DEBRIS PRESENT. AN EXTENSIVE SYNOVECTOMY WAS PERFORMED FREEING THE MEDIAL AND LATERAL GUTTERS. AN EXTENSIVE SOFT TISSUE SLEEVE WAS RAISED OFF THE MEDIAL TIBIA. THE PATELLA BUTTON WAS INSPECTED. IT APPEARED WELL FIXED. THERE WAS A MODERATE AMOUNT OF PLASTIC LOSS NOTED MEDIALLY. THE POLYETHYLENE INSERT SEPARATING THE TIBIA AND THE FEMUR WAS THEN REMOVED. THERE WAS BURNISHING AND WEAR NOTED MEDIALLY AND LATERALLY. PATIENT AWAKENED, RETURNED FROM THE OPERATING ROOM TO THE RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21026849 ↗
• InjuryDec 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 99 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, SYNOVITIS, FAILURE OF IMPLANT, OSTEOLYSIS, SWELLING/ EDEMA, AND IMPLANT PAIN. 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. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 20896931 ↗
• InjuryDec 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 85 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, TISSUE BREAKDOWN, SYNOVITIS, OSTEOLYSIS, AND PAIN. 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. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Synovitis; Tissue Breakdown

  MAUDE report 20892119 ↗
• InjuryNov 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 72 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SWELLING/ EDEMA, PAIN AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20678118 ↗
• InjurySep 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA CLINICAL STUDY, APPROXIMATELY 4 YEARS, 7 MONTHS, AND 19 DAYS POST-OPERATIVELY OF A LEFT TKA, THE PATIENT PRESENTED WITH POLYETHYLENE WEAR WITH EVIDENCE OF OSTEOLYSIS. SWELLING IN LEFT KNEE, SURGEON REPORTS THIS IS DUE TO THE POLYETHYLENE WEAR WHICH IS VISIBLE ON THE X-RAY WITH EVIDENCE OF OSTEOLYSIS. 2 YEARS, 8 MONTHS, AND 5 DAYS FOLLOWING, THE PATIENT EXPERIENCED LUCENCY. LUCENCY DISCOVERED UNDERNEATH MEDIAL TIBIAL PLATEAU, LATERAL FEMORAL CONDYLE AND MEDIAL FEMORAL CONDYLE. THE ACTION TAKEN IS OTHER - REVIEW IN 6 MONTHS, OR EARLIER IF SUBJECT BECOMES SYMPTOMATIC. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING. THE CASE REPORT FORM DOES NOT INDICATE WHETHER THIS EVENT IS RELATED TO THE DEVICE AND/OR TO THE PROCEDURE.

  Patient problems: Inadequate Osseointegration; Insufficient Information; Osteolysis; Swelling/ Edema

  MAUDE report 20194453 ↗
• InjuryJun 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN. THE REASON FOR THE LEFT KNEE REVISION WAS STATED TO BE FOR "LOOSE FEMUR AND BAD POLY". THE PATIENT HAD A REVISION SURGERY APPROXIMATELY 7 YEARS, 4 MONTHS POST IMPLANT. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF A DEVICE, OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19606217 ↗

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-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• 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