Optetrak Logic 02-010-01-0230Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10885862001146), received between Feb 11, 2020 and May 11, 2026 — classified as 44 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (29 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED. THE PATIENT HAD DONE WELL, BUT DEVELOPED PAIN, SWELLING, AND 'CRACKLING' IN THEIR KNEE. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. SUMMARY OF PRESENTATION OF 5 PATIENTS: (ADD THIS TO ALL CASES ABOVE) THE VAST MAJORITY (>90%) OF PATIENTS ARE NOT EXPERIENCING SYMPTOMS SYMPTOMS INCLUDE PAIN, SWELLING, INSTABILITY,¿ CRACKLING,¿ AND POSTERIOR KNEE / CALF MASS SIGNS INCLUDE EFFUSION, TTP, STIFFNESS, INSTABILITY. RADIOGRAPHIC FEATURES RANGE FROM COMPLETELY NORMAL TO GROSS POLYETHYLENE THINNING, OSTEOLYSIS, IMPLANT LOOSENING, AND SOFT TISSUE MASS. SURGICAL FINDINGS INCLUDE COMPLETE LOOSENING OF POLYETHYLENE COMPONENT WITH PRISTINE CEMENT MANTLE, SYNOVITIS, OSTEOLYSIS, AND POLYETHYLENE PITTING / DELAMINATION.

  Patient problems: Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 25143162 ↗
• InjuryApr 7, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL NOTIFICATION, APPROXIMATELY 10 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND OSTEOLYSIS. THE OPERATIVE REPORTED NOTED THAT THERE WAS WEAR OF THE POLYETHYLENE LINER, AND THERE WAS NO EVIDENCE OF INFECTION. POSTERIOR SYNOVITIS, SCAR TISSUE AND OSTEOPHYTES WERE REMOVED. THE PATELLA WAS NOTED TO BE WELL FIXED, BUT THERE WAS SOME WEAR. PER THE AVAILABLE INFORMATION, THE PATIENT ALLEGES THEY HAVE SUFFERED AND CONTINUE TO SUFFER PERMANENT AND DEBILITATING INJURIES 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; Aseptic loosening; Cyst(s); Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 24798912 ↗
• InjuryMar 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY WITH NO BONE LOSS. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. THE PATIENT STARTED EXPERIENCING PAIN AND INFLAMMATION SINCE 2021. ADDITIONAL INFORMATION RECEIVED INDICATED THE FEMORAL COMPONENT WAS NOT OSSEOINTEGRATED TO THE BONE. THE COMPONENT CAME LOOSE BY HAND.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 24489205 ↗
• InjuryNov 12, 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 141 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR PAIN, ASEPTIC LOOSENING OF THE PATELLA COMPONENT, AND MARKED OSTEOLYSIS FROM POLYETHYLENE WEAR. ADDITIONAL INFORMATION RECEIVED FROM THE OPERATIVE REPORT NOTED THAT THE PATIENT PRESENTED WITH A PAINFUL AND UNSTABLE LEFT KNEE REPLACEMENT. THE PATIENT WAS NOTED TO HAVE ASEPTIC LOOSENING OF THE PATELLA COMPONENT AND MARKED OSTEOLYSIS FROM POLYETHYLENE WEAR. THE PATIENT HAS FAILED CONSERVATIVE MANAGEMENT INCLUDING ACTIVITY MODIFICATION AND ANTI-INFLAMMATORY MEDICATIONS. THE PATIENT DECIDED TO PROCEED WITH A REVISION LEFT TOTAL KNEE REPLACEMENT. A PARTIAL FAT PAD EXCISION WAS PERFORMED. THE PATELLA WAS SUBLUXATED LATERALLY. 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 WEAR OF THE LINER. NEXT, THE FEMORAL COMPONENT WAS REMOVED. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH OSTEOLYSIS ESPECIALLY ANTERIORLY. THERE WAS NO EVIDENCE OF INFECTION GROSSLY ALTHOUGH MULTIPLE SPECIMENS WERE SENT TO PATHOLOGY. ATTENTION WAS

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

  MAUDE report 23536179 ↗
• InjuryMay 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 12 YEARS POST INITIAL OPERATION. FEMUR WAS FOUND TO BE LOOSE. ALL COMPONENT WERE REMOVED AND REVISED TO A COMPETITOR'S DEVICE. THE PATIENT WAS IN STABLE CONDITION AND HAD NO KNOWN ISSUES WITH THE SURGERY. NO FURTHER INFORMATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22003306 ↗
• InjuryFeb 20, 2025Loss of or Failure to Bond; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 134 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT SURGERY, THE PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY TO ADDRESS PAIN, SWELLING AND INSTABILITY. A REVISION OPERATIVE REPORT WAS PROVIDED. IT WAS NOTED THAT A PREOP WORKUP WAS DONE AND NEGATIVE FOR INFECTION. POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING LEFT TOTAL KNEE REPLACEMENT, INSTABILITY, AND OSTEOLYSIS. INTRAOPERATIVELY, IT WAS NOTED THE PATELLA WAS FOUND TO BE WELL FIXED. THE SURGEON OBSERVED EVIDENCE OF YELLOW STAINING, PITTING AND SCRATCHING TYPE POLY WEAR. THE FEMORAL WAS FOUND TO BE SIGNIFICANTLY LOOSE WITH EVIDENCE OF DEBONDING OF THE IMPLANT-CEMENT INTERFACE WITH NO ATTACHED BONE OR CEMENT ON THE BACK SIDE OF THE FEMORAL IMPLANT AND REVEALED BONE LOSS. THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE WITH NO ADDITIONAL BONE LOSS. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21420310 ↗
• InjuryDec 31, 2024Unstable; 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 53 MONTHS AFTER HAVING A LEFT TOTAL KNEE REPLACEMENT THE PATIENT UNDERWENT A REVISION SURGICAL PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, PAIN AND INSTABILITY. THE POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING TIBIAL COMPONENT AND OSTEOLYSIS. INTRAOPERATIVELY, THE SURGEON OBSERVED SIGNIFICANT SYNOVITIS, WEAR OF THE POLYETHYLENE LINER AND SIGNIFICANT FIBROUS TISSUE WITH OSTEOLYSIS BENEATH THE FEMORAL COMPONENT. IT WAS NOTED THERE WAS NO EVIDENCE OF INFECTION. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE AND EASILY REMOVED AND WITH OSTEOLYSIS BENEATH AT THE MEDIAL ASPECT. THE PATELLA WAS NOTED TO BE WELL FIXED, BUT WITH SOME WEAR WITH OSTEOLYSIS THAT WAS DEBRIDED. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21047045 ↗
• InjuryDec 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 136 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, OSTEOLYSIS, SYNOVITIS, AND FAILURE OF IMPLANT. 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: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 20928732 ↗
• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 110 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, FAILURE OF IMPLANT, IMPLANT PAIN, OSTEOLYSIS, AND SYNOVITIS. 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: Failure of Implant; Implant Pain; Osteolysis; Synovitis

  MAUDE report 20907306 ↗
• InjuryDec 11, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 11 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO JOINT PAIN, JOINT SWELLING AND STIFFNESS, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, TISSUE DAMAGE, REVISION SURGERY, INSTABILITY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS. 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; Arthralgia; Joint Laxity; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 20906785 ↗
• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 103 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, FAILURE OF IMPLANT, 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: Failure of Implant; Osteolysis; Pain

  MAUDE report 20902958 ↗
• InjuryDec 4, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; 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 5 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020. THE PATIENT HAS EXPERIENCED MECHANICAL LOOSENING FEMORAL COMPONENT, DAMAGED POLY INSERT COMPONENT, SYNOVITIS AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. SYNOVECTOMY WAS PERFORMED REMOVING SCAR TISSUE AND INFLAMED SYNOVIUM. THE TIBIAL INSERT WAS NOTED TO BE GOUGED AND DAMAGED. THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND SEPARATED FROM THE CEMENT. THE PATIENT WAS TRANSPORTED IN STABLE CONDITION TO THE RECOVERY ROOM. 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: Pain; Synovitis

  MAUDE report 20844047 ↗
• InjuryNov 13, 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 32 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SEVERE ANKYLOSIS OF THE LEFT KNEE, LOSS OF RANGE OF MOTION, PERSISTENT PAIN, SWELLING, SYNOVITIS AND EMOTIONAL CHANGES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ankylosis; Emotional Changes; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20675289 ↗
• InjurySep 11, 2024Unstable; 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 92 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, OSTEOLYSIS, ASEPTIC 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: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 20190850 ↗
• InjuryAug 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 129 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PATELLA POLYETHYLENE WEAR, SIGNIFICANTLY AT THE SUPERIOR 3RD. 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: Osteolysis

  MAUDE report 20039564 ↗
• InjuryAug 21, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 150 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS, LOOSENING, DEBONDING, AORI TYPE 2B BONE LOSS. 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; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 20014746 ↗
• InjuryAug 21, 2024Unstable; 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 30 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING,ASEPTIC LOOSENING, DEBONDING. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20010123 ↗
• InjuryAug 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 100 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED LEFT KNEE ASEPTIC LOOSENING FROM DEFECTIVE EXACTECH POLYETHYLENE. FINDINGS: LOOSE FEMUR. WELL FIXED TIBIA. WELL FIXED PATELLA BUTTON. AORI 1 BONE LOSS ON FEMUR DUE TO OSTEOLYSIS SECONDARY TO RECALLED EXACTECH KNEE. AORI TYPE 1 BONE LOSS ON TIBIA DUE TO OSTEOLYSIS SECONDARY TO RECALLED EXACTECH KNEE. THE PATIENT PRESENTS WITH LEFT KNEE PAIN AND DIFFICULTY AMBULATING. SHE UNDERWENT A TOTAL KNEE REPLACEMENT PREVIOUSLY WITH A NOW RECALLED EXACTECH TOTAL KNEE ARTHROPLASTY IMPLANT. HISTORY, PHYSICAL EXAMINATION, AND IMAGING SUGGESTED ASEPTIC LOOSENING. DESCRIPTION OF PROCEDURE: SYNOVECTOMY WAS PERFORMED USING A BOVIE. THE PATELLA FOUND TO BE WELL FIXED. THE PATELLA HAD SIGNIFICANT HETEROTOPIC OSSIFICATION MEDIALLY AND LATERALLY WHICH IMPEDED EXPOSURE. THE BONE WAS EXPOSED AND EXCISED. THE POLYETHYLENE INSERT WAS REMOVED USING AN OSTEOTOME. ATTENTION WAS TURNED TO THE FEMUR. THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE AND WAS REMOVED WITH A BONE TAMP AND MALLET. CEMENT WAS REMOVE

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

  MAUDE report 19916829 ↗
• InjuryAug 2, 2024Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 34 MONTHS AFTER A LEFT KNEE REVISION SURGICAL PROCEDURE, THE PATIENT UNDERWENT A SECOND REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, STIFFNESS, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, TISSUE DAMAGE, REVISION SURGERY, RECONSTRUCTION SURGERY, DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, AND BONE LOSS. A POST OPERATIVE REPORT WAS PROVIDED. THE POST OPERATIVE DIAGNOSIS WAS NOTED AS CHRONIC PERIPROSTHETIC LEFT TOTAL KNEE REPLACEMENT INFECTION. INTRAOPERATIVELY, THE SURGEON OBSERVED SYNOVIUM IN THE SINUS TRACT THROUGH THE MEDIAL FASCIA OVER THE PROXIMAL MEDIAL TIBIA, LOOSE FEMORAL COMPONENT, WELL FIXED TIBIAL COMPONENT, PURULENT FLUID WITHIN THE SINUS TRACT. THERE WAS SLIGHT LAXITY THROUGHOUT THE RANGE OF MOTION TO VARUS AND VALGUS WHEN TAKING THE KNEE INTO EXTENSION. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS 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; Emotional Changes; Joint effusion; Loss of Range of Motion; Medical device site infection; Muscle/Tendon Damage; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19893897 ↗
• InjuryJun 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 19512896 ↗
• InjuryMay 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE 66 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 3 YEARS POST OP. PATIENT HAD FALLEN AND WAS HAVING PAIN WITH KNEE. THE 11MM SIZE 3 LINER AND 32MM PATELLA WERE REMOVED AND WHILE INSPECTING THE PROSTHESIS THE FEMORAL COMPONENT HAD BECOME LOOSE. THE SURGEON RECEMENTED A NEW FEMORAL COMPONENT AND IMPLANTED AN 11MM PSC SIZE 3 IMPLANT AND 35MM PATELLA. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISCARDED AT THE HOSPITAL

  Patient problems: Failure of Implant; Fall; Implant Pain

  MAUDE report 19259160 ↗
• InjuryFeb 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 13 YEARS POST INITIAL LEFT TKA, THE 69 Y/O FEMALE PATIENT WAS HAVING PAIN. PATIENT HAD A LOOSE FEMUR THAT WAS IN FLEXION. PATIENT WAS REVISED TO FEMUR SIZE 3 CONSTRAINED, WITH POSTERIOR AND DISTAL AUGMENTS, 2° COUPLER, 16 X 1 20 STEM AND A H 32 SMALL CONE FEMORAL. A 3/15MM CONSTRAINED LINER. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS ATTACHED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THEY WERE HELD BY HOSPITAL.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18739669 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE 54 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2012 AND PRESENTED ON (B)(6) 2023 WITH INFECTION - SEPTIC LEFT TOTAL KNEE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. IT IS ALSO INDICATED THAT THE FOLLOWING ACTION(S) WERE TAKEN IRRIGATION/DEBRIDEMENT/IMPLANT REMOVAL/ANTIBIOTIC SPACER PREIMPLANTATION AFTER IV ANTIBIOTICS FOR 6 WEEKS. THE OUTCOME OF THIS EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2023. (B)(6) 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3. 510K: K033883. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 18611539 ↗
• InjuryOct 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2010. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED ON (B)(6) 2023 DUE TO A LOOSE FEMUR AND RECALLED POLY. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 17964808 ↗
• InjuryAug 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO A LOOSE FEMUR AND THE POLY RECALL. 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: Ambulation or Postural Difficulties; Failure of Implant; Inflammation; Joint effusion; Scar Tissue; Synovitis

  MAUDE report 17616658 ↗

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