Optetrak Logic 02-012-45-3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10885862003966), received between Sep 19, 2022 and Apr 20, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (13 reports).

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS AND COMPONENT LOOSENING. AS A RESULT, APPROXIMATELY NINE YEARS AND SIX MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. IT WAS NOTED THAT THERE WAS SIGNIFICANT REACTIVE TISSUE ABOUT BOTH THE FEMORAL AND TIBIAL COMPONENTS, THEY WERE GROSSLY LOOSE, THERE WAS GROSS FRACTURE OF THE POLYETHYLENE. THE PATELLAR BUTTON HAD MINIMAL ABRASIVE WEAR. THERE WAS A LOT OF OSTEOLYTIC DEBRIS PRESENT THROUGHOUT THE KNEE. 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 4 OF 4 FOR THIS EVENT/PATIENT.

  Patient problems: Discomfort; Joint effusion; Osteolysis; Pain

  MAUDE report 24927171 ↗
• InjuryMar 3, 2026Naturally Worn

  REPORT #1 OF 2 FOR THIS EVENT. IT WAS REPORTED A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, STIFFNESS, AND SWELLING. AS A RESULT, APPROXIMATELY FIVE (5) LATER THE PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION PROCEDURE DUE TO PROSTHESIS WEAR. AN OPERATIVE REPORT WAS PROVIDED. INTRAOPERATIVELY, SCAR TISSUE WAS OBSERVED AND WAS DEBRIDED. THE TIBIAL INSERT WAS NOTED TO BE SIGNIFICANTLY WORN WITH FULL THICKNESS LOSS OF POLYETHYLENE SUBSTANCE. THE TIBIAL AND FEMORAL COMPONENTS WERE NOTED TO BE WELL FIXED. THE PATELLA COMPONENT WAS NOTED TO BE WORN OF THE POLYETHYLENE. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL. NO FURTHER PATIENT IMPACT WAS REPORTED. PRE-OPERATIVE X-RAYS WERE PROVIDED. THE EXPLANTS WERE RECEIVED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 24502622 ↗
• MalfunctionMar 14, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE OF A RIGHT TKA, THE SURGEON WAS NOT ABLE TO LOCK THE POLYETHYLENE INSERT INTO PLACE IN THE APPROPRIATE FASHION. THERE WAS OBVIOUS LOOSENESS AND INSTABILITY ASSOCIATED WITH THE COMPONENT. IT DID NOT APPEAR THAT THERE WAS OBVIOUS DAMAGE TO THE LOCKING MECHANISM ALTHOUGH THE SURGEON SUSPECTED THIS WAS LIKELY THE CASE GIVEN THE NEAR COMPLETE WEAR THROUGH OF POLYETHYLENE POSTERIORLY. ANOTHER NEW POLYETHYLENE WAS BROUGHT TO THE FIELD AS WELL. AGAIN, THE SURGEON WAS NOT ABLE TO SECURE THIS INTO PLACE USING THE STANDARD LOCKING MECHANISM. GIVEN THE INABILITY TO SECURE THE POLY, PLANS CHANGED TO A COMPLETE REVISION. THE SURGEON CAREFULLY REMOVED THE FEMORAL AND TIBIAL COMPONENTS. TIBIA AND FEMUR WERE REAMED. FULLY CEMENTED STEMS FOR TIBIA AND FEMUR WERE SELECTED. THERE WAS SIGNIFICANT BONE LOSS CENTRALLY AND A CONE WAS PREPPED FOR LATER PLACEMENT. 10 MM POSTERIOR AUGMENTS USED LATERALLY. CEMENT RESTRICTORS USED IN BOTH FEMUR AND TIBIA. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS AVAILABLE. THEY WERE SENT TO THE LAB AND LEGAL DEPARTMENT AT THE HOSPIT

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610155 ↗
• InjuryMar 6, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL LEFT SIDE TKA, THE FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR. PATIENT WAS REVISED INTO A LOGIC PS TKR. 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 AS THEY WERE DISPOSED AT THE HOSPITAL, NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21538129 ↗
• InjuryFeb 11, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, BALANCE PROBLEMS, IMPLANT PAIN, JOINT LAXITY, LOSS OF RANGE OF MOTION, OSTEOLYSIS, SCAR TISSUE, AND SWELLING/EDEMA. 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; Balance Problems; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Scar Tissue; Swelling/ Edema

  MAUDE report 21354337 ↗
• InjuryJan 29, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT TKA ON 16 DEC 2013 DUE TO SEVERE OSTEOARTHRITIS, RHEUMATOID ARTHRITIS. THEY SUBSEQUENTLY UNDERWENT LEFT TKA REVISION SURGERY ON 05 JUL 2017, APPROXIMATELY 3 YEARS 7 MONTHS AFTER THEIR INITIAL IMPLANTATION. IN THE YEARS FOLLOWING THE SURGERIES, THE PATIENT EXPERIENCED PAIN, SWELLING, INSTABILITY, AND BONE LOSS ON BOTH KNEES CAUSED BY EARLY AND ACCELERATED POLYETHYLENE WEAR AND/OR COMPONENT LOOSENING. ULTIMATELY, ON JULY 5, 2017, PLAINTIFF UNDERWENT AN EXTENSIVE REVISION SURGERY ON HER LEFT KNEE. 05 JUL 2017 OP REPORT: ONE-STAGE REVISION INFECTED LEFT TOTAL KNEE WITH REMOVAL OF ALL INFECTED COMPONENTS, RADICAL DEBRIDEMENT SYNOVECTOMY, AND PLACEMENT OF IN-GROWTH KNEE CONSTRUCT. REPORT STATES THAT THERE WAS YELLOW APPEARING PURULENT MATERIAL IN THE JOINT AND THERE WERE ALSO SIGNS OF METAL-WEAR DEBRIS WITH DARK-STAINED SYNOVIAL TISSUE, AS WELL AS EVIDENCE OF MICROMOTION BETWEEN THE METAL AUGMENT AND THE TIBIAL TRAY. 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: Joint Laxity; Medical device site infection; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21263476 ↗
• InjuryJan 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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. PATIENT EXPERIENCED OSTEOLYSIS, PAIN AND FAILURE OF IMPLANT. 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. 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. REVISED TO ANOTHER COMPANY'S DEVICES. PATIENT SENT TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 21233328 ↗
• InjuryJan 10, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INSTABILITY, JOINT LAXITY, PAIN, SWELLING AND EDEMA. 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: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21125317 ↗
• InjuryJan 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, FAILURE OF IMPLANT, 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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 21072209 ↗
• InjuryDec 12, 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, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE APPROXIMATELY 8 YEARS AND 3 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 20914845 ↗
• 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 20905881 ↗
• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 98 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, FAILURE OF IMPLANT, OSTEOLYSIS, SYNOVITIS, 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; Synovitis

  MAUDE report 20904553 ↗
• 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 20902863 ↗
• InjuryDec 5, 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 RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THE PREVIOUS LINER WAS DISLODGED FROM THE TIBIAL COMPONENT. UPON INSPECTION THERE WAS SEVERE DELAMINATION WEAR ON THE SURFACE OF THE POLYETHYLENE. BOTH TIBIAL AND FEMORAL COMPONENTS HAD AREA OF SEVERE OSTEOLYSIS LEADING TO DEBONDING AT THE BONE CEMENT JOINT. PATELLAR COMPONENT FOUND TO BE SIGNIFICANTLY WORN. THE PATIENT TOLERATED THE PROCEDURE WELL. 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: Implant Pain; Osteolysis; Scar Tissue; Swelling/ Edema

  MAUDE report 20858075 ↗
• InjuryOct 30, 2024Unstable; Migration; Unstable; Migration

  APPROXIMATELY 6 YEARS AND 28 DAYS POST-OPERATIVELY OF A RIGHT TKA, IT WAS REPORTED VIA CLINICAL STUDY, THAT THE PATIENT EXPERIENCED PREPATELLAR BURSITIS OF THE RIGHT KNEE CAUSING PAIN, SWELLING, AND LOCKING IN RIGHT KNEE JOINT. SMALL JOINT EFFUSION AND PREPATELLAR SUBCUTANEOUS EDEMA WAS NOTED ON THE MRI. THE TREATMENT RECOMMENDED WAS EXPLORATION OF KNEE JOINT WITH REVISION OF TIBIAL INSERT AND REBALANCING OF KNEE JOINT. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 20567926 ↗
• InjurySep 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 130 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ENCAPSULATED POLYETHYLENE DEBRIS WITHIN THE SYNOVIUM, SEVERE OSTEOLYSIS ON FEMUR AND MODERATE ON TIBIA, SEVERE WEAR OF TIBIAL INSERT, GROSSLY LOOSE FEMORAL, PARTIALLY LOOSE TIBIAL TRAY . 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; Synovitis

  MAUDE report 20241351 ↗
• 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 LOOSENINGASEPTIC LOOSENING, OSTEOLYSIS. 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 20012538 ↗
• InjuryJun 27, 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 LEFT TOTAL KNEE ARTHROPLASTY AND THEN APPROXIMATELY 4 YEARS, 8 MONTHS LATER WAS REVISED. PATIENT CLAIMS REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, INSTABILITY, AND COMPONENT LOOSENING. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: PAINFUL AND LOOSE LEFT TOTAL KNEE. ¿THE FEMUR, TIBIA AND PATELLA COMPONENTS WERE FOUND TO BE COMPLETELY LOOSE.¿ THE PATIENT'S BMI AND BODY MORPHOLOGY MADE THE REVISION CASE MORE DIFFICULT. THERE IS INCOMPLETE INFORMATION ON THE SURGICAL PROCEDURE WITHOUT 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; Aseptic loosening; Discomfort; Joint Laxity; Pain

  MAUDE report 19630363 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 9 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. FROM REVISION OPERATIVE REPORT- "TIBIA FRACTURE POSTERIOR LATERAL DURING EXTRACTION OF THE IMPLANTS.¿ 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: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 17702903 ↗
• InjurySep 19, 2022Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO WEAR OF THE INSERT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER MEDICAL HISTORY/PATIENT INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 15447759 ↗