{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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SURGEON REPORTED THAT THE DISTAL FEMUR METAPHYSIS LOOKED \"DISINTEGRATED.\" PATIENT'S KNEE CONSTRUCT WAS REVISED TO A HINGED DISTAL FEMUR CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED TIBIAL BASEPLATE OR INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, PRE- AND POST-REVISION X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED." }, { "mdr_text_key": "321692549", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: \"IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT. SURGEON REPORTED THAT THE DISTAL FEMUR METAPHYSIS LOOKED \"DISINTEGRATED.\" PATIENT'S KNEE CONSTRUCT WAS REVISED TO A HINGED DISTAL FEMUR CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED TIBIAL BASEPLATE OR INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, PRE- AND POST-REVISION X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.¿. PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES WAS NOT PERFORMED AS CASE SESSION DATA WAS NOT PROVIDED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT INDICATED: UNDATED X-RAYS: AP AND LAT LEFT KNEE DEMONSTRATING UNCEMENTED TKA WITH GROSSLY LOOSE FEMORAL COMPONENT. UNDATED X-RAY: AP LEFT KNEE DEMONSTRATING CEMENTED, MODULAR, LONG-STEM, DISTAL FEMORAL REPLACEMENT, HINGED TKA - REDUCED AND NOMINAL POSITION. NO CLINICAL OR PMH, NO PATIENT DEMOGRAPHICS, NO OPERATIVE REPORTS, NO EXAMINATION OF EXPLANTED COMPONENTS, NO SURGICAL PATHOLOGY REPORTS, NO DATED SERIAL X-RAYS. WHILE THE X-RAYS APPEAR TO CONFIRM THE EVENT DESCRIPTION, INSUFFICIENT DATA IS PRESENT TO CREATE A MEDICAL REPORT FOR THIS CASE.\". PRODUCT HISTORY REVIEW. A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROB WAS INSPECTED ON 26 FEBRUARY 2019 AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW. A SEARCH OF THE COMPLAINT DATABASE UNDER DEVICE IDENTIFICATION PN 219999, ROB REPORTS SIMILAR COMPLAINTS FOR TKA SOFTWARE ¿ OTHER. CONCLUSIONS: THE X-RAYS APPEAR TO CONFIRM THE LOOSENING OF THE FEMORAL COMPONENT BUT INSUFFICIENT DATA IS PRESENT TO THE ROOT CAUSE. FURTHER INFORMATION SUCH AS RETURN OF THE CASE SESSION/LOG DATA, CLINICAL OR PATIENT MEDICAL HISTORY, OPERATIVE REPORTS, PROGRESS NOTES, DATED SERIAL X-RAYS AND SURGICAL PATHOLOGY REPORTS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "205099839", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "205099840", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT. SURGEON REPORTED THAT THE DISTAL FEMUR METAPHYSIS LOOKED \"DISINTEGRATED.\" PATIENT'S KNEE CONSTRUCT WAS REVISED TO A HINGED DISTAL FEMUR CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED TIBIAL BASEPLATE OR INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, PRE- AND POST-REVISION X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/19/2020" } ] }