Optetrak Logic 02-010-01-0335Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10885862001245), received between Oct 14, 2019 and May 27, 2025 — classified as 27 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (23 reports).

2 other recalls cover devices cleared under the same FDA submission (K093360); 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. THE PATIENT WAS REVISED APPROXIMATELY 4 YEARS 3 MONTHS POST OPERATION. SUBSEQUENTLY, PATIENT EXPERIENCED JOINT EFFUSION WITHOUT TENSION, COLD KNEE, AND A SURGICAL WOUND WITHOUT ABNORMALITIES. PATIENT HAD PAIN RELATED TO THE TIBIAL COMPONENT WITH MEDIAL INSTABILITY BUT HAD FULL RANGE OF MOTION.

  Patient problems: Granuloma; Inadequate Osseointegration; Joint Laxity; Joint effusion; Osteolysis; Pain

  MAUDE report 22088260 ↗
• InjuryMar 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 117 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. THE REVISING SURGEON NOTED LOOSENING OF THE FEMORAL COMPONENT, AS WELL AS BONY DEFECTS IN BOTH THE FEMUR AND TIBIA. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21539125 ↗
• InjuryJan 14, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THE FEMALE PATIENT HAD A REVISION OF FEMUR AND POLY WITH STEM/AUGMENTS. PATIENT WAS REVISED TO AN EXACTECH CC FEMUR, STEM AUGMENTS AND CC INSERT. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTO/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO PATIENT'S LAWYER REQUESTED IMPLANTS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Osteolysis; Scar Tissue

  MAUDE report 21148908 ↗
• InjuryDec 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 71 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, AMBULATION OR POSTURAL DIFFICULTIES, DISCOMFORT, PAIN, OSTEOLYSIS, FAILURE OF IMPLANT, AND SYNOVITIS. 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; Discomfort; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 21034420 ↗
• InjuryDec 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PER A REPORT FROM THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT KNEE REPLACEMENT. APPROXIMATELY 9 YEARS AND 4 MONTHS LATER, THE PATIENT HAD RIGHT KNEE REVISION (OP REPORT ATTACHED). DIAGNOSIS DURING THE REVISION WAS TO ASEPTIC LOOSENING. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Pain; Synovitis

  MAUDE report 21021664 ↗
• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 112 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, SYNOVITIS, FAILURE OF IMPLANT, OSTEOLYSIS, SWELLING/ EDEMA, IMPLANT PAIN, AND JOINT EFFUSION. 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; Implant Pain; Joint effusion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 20902204 ↗
• InjuryDec 10, 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 108 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, LOOSENING AND OSTEOLYSIS. PATIENT ALSO EXPERIENCED JOINT LAXITY. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT AND LOOSE FEMORAL AND TIBIAL COMPONENTS. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 20892270 ↗
• InjuryOct 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE: USA. RELATED CASE (B)(4) LK REV. AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 5 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 DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON 21 NOV 2022. PRINCIPAL DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT DUE TO MECHANICAL LOOSENING. POST-OP DIAGNOSIS: SAME. SIGNIFICANT FIBRINOUS DEBRIS WAS ENCOUNTERED INTO THE JOINT WITH A TANDEM WHITISH COLOR THIS TISSUE WAS HIGHLY FRIABLE WAS FOUND THROUGHOUT THE SUPRAPATELLAR POUCH AS WELL AS IN THE GUTTERS. THIS WAS EXCISED AND THE KNEE IN ORDER TO FULLY DEBRIDED TO VISUALIZE ALL THE COMPONENTS THEN REMOVES SIMILAR DEBRIS FROM THE ANTERIOR INTERVAL AS WELL AS DID ARE NORMAL MEDIAL RELEASE. WE THEN REMOVED THE POLYETHYLENE INSERT WITH A SINGLE PRONG RETRACTOR. THE POLY WAS NOTED TO BE YELLOW WITH SIGNIFICANT PITTING AND LOSS OF THICKNESS IN THE MEDIAL LATERAL COMPARTMENT WITH CENTRAL PITTING AND ROUGHNESS NOTED ON

  Patient problems: Joint Laxity

  MAUDE report 20569557 ↗
• InjuryOct 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A 69 YO MALE PATIENT, INITIAL RIGHT TOTAL ARTHROPLASTY IN (B)(6) 2016, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 7 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. SINCE (B)(6) 2023, THE PATIENT HAD SUFFERED FROM RIGHT KNEE PAIN: THE KNEE WAS SWOLLEN WHEN HE WALKED FOR 30 MINUTES, CYCLED, STOOD STATICALLY FOR MORE THAN 20 MINUTES OR DROVE. TAKING PAINKILLERS AND CORTISONE DID NOTHING TO CHANGE THIS SITUATION; THE PATIENT LAY OR SAT WITHOUT BEING ABLE TO DO ANY SPORT, GO OUT OR TRAVEL. HE COULD DO SOME LIMITED DOMESTIC CHORES: SHOPPING, HOUSEWORK AND GARDENING. ON (B)(6) 2024, THE PATIENT CONSULTED HIS SURGEON, WHO DECIDED TO OPERATE ON (B)(6) 2024. THE SURGEON PERFORMED A REVISION OF THE RIGHT TOTAL KNEE PROSTHESIS WITH AN ENLARGED SYNOVECTOMY AND BONE RECONSTRUCTION. THE ENTIRE PROSTHESIS WAS COMPLETELY REPLACED BY A SEMI-CONSTRAINED PROSTHESIS, DUE TO FEMORAL AND TIBIAL LOOSENING. THE SURGEON TOLD THE PATIENT THAT THE PROSTHESIS WAS DEFECTIVE. ON DISCHARGE, THE PATIENT WAS HOSPITALIZED FOR THREE WEEKS AT HOME WITH DRESSING AND PHYSIOTHERAPY. HE RESUMED DRIVING ON (B)(6) 2024, AND SOME ACTIVITIES IN (B)(6) 2024.

  Patient problems: Joint effusion; Osteolysis; Pain

  MAUDE report 20522714 ↗
• InjuryOct 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT UNDERWENT A REVISION OF THE RIGHT KNEE DUE TO PAIN AND THE POLYETHYLENE RECALL. THE FEMORAL COMPONENT APPEARED TO BE LOOSE SO THE SURGEON REVISED EVERYTHING TO COMPETITOR DEVICES. HE MENTIONED THAT THERE WAS DEBONDING AT THE CEMENT INTERFACE OF THE FEMORAL COMPONENT. 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: Pain

  MAUDE report 20403702 ↗
• InjuryAug 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 71 Y/O FEMALE PATIENT RIGHT KNEE WAS REVISED 4 YEARS 2 MONTHS POST OP. EVERYTHING WAS REVISED DUE TO OSTEOLYSIS, LOOSENING OF FEMUR, PATELLA AND TIBIAL INSERT WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISCARDED AT THE HOSPITAL.

  Patient problems: Osteolysis

  MAUDE report 19914112 ↗
• InjuryJul 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 121 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND DEBILITATION, MODERATE EFFUSION, LOOSENING OF FEMUR, SEVERE FEMORAL OSTEOLYSIS, SEVERE WEAR OF POLYETHYLENE LINER AND PATELLA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANTS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19667530 ↗
• InjuryJun 5, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 64 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY. IT WAS OBSERVED THERE WAS ¿LARGE AMOUNTS OF WEAR¿ ON THE POLYETHYLENE TIBIAL INSERT, AS WELL AS ¿A LOT OF REACTIVE SYNOVIAL TISSUE WITH GRANULATION.¿ THE OPERATIVE SURGEON ALSO NOTED MECHANICAL LOOSENING OF THE FEMORAL IMPLANT, AND CAVITARY LESIONS ON THE FEMUR. THE OPERATIVE SURGEON REVISED THE RIGHT KNEE AND REPLACED THE TIBIAL AND FEMORAL COMPONENTS. 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; Implant Pain; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 19470512 ↗
• InjuryApr 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 9 YEARS AND 6 MONTHS AFTER INITIAL IMPLANT. OP REPORT - POSTOPERATIVE DIAGNOSIS; ARTICULAR BEARING, ASEPTIC LOOSENING NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19103955 ↗
• InjuryDec 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2017. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO THE RECALL OF THE POLY, HOWEVER, WHEN THE SURGEON TAPPED ON THE FEMUR IT SHOWED SIGNS OF LISTENING, SO HE REVISED THE FEMUR AS WELL. 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: Discomfort; Failure of Implant; Pain

  MAUDE report 18253684 ↗
• InjuryJun 9, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED DUE TO SEVERE OSTEOLYSIS NOTED ON X-RAYS. FEMORAL COMPONENTS WERE LOOSE ONCE DISSECTION WAS COMPLETED. ALL COMPONENTS WERE SUBSEQUENTLY REMOVED AND REPLACED WITH COMPETITORS COMPONENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING- HOSPITAL POLICY.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 17097082 ↗
• InjuryApr 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, ON OR ABOUT (B)(6) 2016, THIS PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS IN HER RIGHT KNEE. AT SOME POINT AFTERWARD, SHE PRESENTED FOR AN EVALUATION OF HER RIGHT KNEE, AS SHE HAD BEEN COMPLAINING OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN. ON OR ABOUT (B)(6) 2020, APPROXIMATELY 4 YEARS AND 4 MONTHS AFTER THEIR INITIAL REPLACEMENT SURGERY, THEY UNDERWENT REVISION OF HER RIGHT KNEE DUE TO IMPLANT LOOSENING AND SIGNIFICANT SYNOVITIS. 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; Balance Problems; Discomfort; Failure of Implant; Pain

  MAUDE report 16800085 ↗
• InjuryOct 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7.5 YEARS POST OP THE INITIAL RIGHT TKA, THIS 62 Y/O FEMALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE'S WILL NOT BE RETURNING.

  Patient problems: Failure of Implant

  MAUDE report 15624819 ↗
• InjuryAug 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS 61 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2015. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE(S) ARE NOT RETURNING AS THE HOSPITAL REFUSES TO RELEASE THEM.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15165504 ↗
• InjuryJul 15, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE LEGAL DEPARTMENT, APPROXIMATELY 4 YEARS POST OP THE INITIAL RIGHT TKA, THIS FEMALE PATIENT WAS REVISED DUE TO IMPLANT LOOSENING AND SIGNIFICANT SYNOVITIS. PATIENT HAD BEEN COMPLAINING OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN. DURING REVISION SURGERY, THE SURGEON NOTED THAT THERE WAS "OBVIOUS IMPLANT LOOSENING" AND THAT THERE WAS "EXTENSIVE SYNOVITIS AND OBVIOUS SHARDS OF POLYETHYLENE VISIBLE". THE SUBSEQUENT POST-OPERATIVE DIAGNOSIS CONFIRMED THAT THE PLAINTIFF'S RIGHT TOTAL KNEE ARTHROPLASTY FAILED DUE TO SIGNIFICANT LOOSENING, WHICH IS RELATED TO THE FAILURE IN THE POLYETHYLENE.

  Patient problems: Failure of Implant

  MAUDE report 15029418 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT SIDE TKA, THIS PATIENT HAD A REVISION DUE TO OSTEOLYSIS. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Osteolysis

  MAUDE report 13485608 ↗
• InjuryDec 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY SIX YEARS POST TKA FEMALE PATIENT (B)(6), PATIENT EXPERIENCED ASEPTIC FEMORAL LOOSENING. PATIENT EXPERIENCED INCREASING PAIN AND LAXITY, AT REVISION WAS PERFORMED FOR FEMORAL COMPONENT LOOSE AT IMPLANT CEMENT INTERFACE. WEAR OF POLY ON POSTERIOR POST. THE EVENT IS POSSIBLY RELATED TO THE DEVICE AND TO THE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 13061303 ↗
• InjuryNov 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE EGPS CLINICAL STUDY DATABASE THAT A PATIENT UNDERWENT ARTHROSCOPIC SURGERY FOR ARTHROFIBROSIS AND PATELLAR CLUNK SYNDROME APPROXIMATELY 9 MONTHS POST INITIAL IMPLANT SURGERY ON HER RIGHT KNEE. BOTH KNEES, RIGHT AND THE CONTRALATERAL LEFT, UNDERWENT ARTHROSCOPIC SURGERY TO REMOVE SCAR TISSUE ABOUT THE PATELLA. THE STUDY INDICATED IT WAS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. OUTCOME INDICATES RESOLVED. NO DEVICES RETURNING AS THEY REMAIN IMPLANTED. THIS REPORT IS FOR THE RIGHT KNEE.

  Patient problems: Scar Tissue

  MAUDE report 12737860 ↗
• InjuryMay 27, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YRS POSTOP THE INITIAL RIGHT LTKA, THIS (B)(6) Y/O MALE PATIENT COMPLAINED OF HAVING PAIN. FEMUR WAS LOOSE AND REVISED TO A CC REVISION KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 11895193 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bone Fracture(s)

  MAUDE report 10808428 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093360. One submission often covers many models, so check the product and lot details in each record.

• 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-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ