{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "NJ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "325 CORPORATE DRIVE", "manufacturer_contact_pcity": "20183150", "event_type": "Injury", "report_number": "3005985723-2025-00353", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250730", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250120", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "07430", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "2018315000", "noe_summarized": "1", "manufacturer_contact_l_name": "WILLIAMS", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "US", "manufacturer_contact_area_code": "201", "date_added": "20250730", "manufacturer_contact_f_name": "KELSEY", "device_date_of_manufacturer": "20240514", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2740037", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250730", "brand_name": "MAKO ROBOTIC ARM 3.1", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAKO SURGICAL CORP.", "manufacturer_d_address_1": "3365 ENTERPRISE AVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "WESTON", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "33331", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "33331", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "219999", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07613327395280", "udi_public": "07613327395280", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Malposition of Device", "Incorrect, Inadequate or Imprecise Result or Readings", "Malposition of Device" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/23/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260123", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "2018", "patient": [ { "patient_sequence_number": "1", "date_received": "20250730", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " O", " R" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Joint Laxity", "Joint Laxity" ] } ], "distributor_city": "", "date_report": "20250919", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "22664681", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250707", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "33331", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MAKO SURGICAL CORP.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "376408010", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WE RECENTLY HAD A SURGEON REACH OUT ABOUT AN OUTCOME OF A TKA 2.0 CASE THAT HAPPENED (B)(6) 2025. THE PATIENT STARTED WITH A NATIVE 8 DEGREE VARUS DEFORMITY. WE PLANNED 4 DEGREES TOTAL OF VARUS. 3 DEGREES OF VARUS ON THE TIBIA AND 1 DEGREE OF VARUS ON THE FEMUR. WE ALSO HAD 1 DEGREE OF EXTERNAL ROTATION. THE SURGEON HAS REACHED AND HAS SAID THE PATIENT IS NOW IN 20 DEGREE OF VALGUS AND IS QUESTIONING WHETHER SOMETHING HAPPENED DURING THE CASE THAT CAUSED THE DRASTIC CHANGE. HE IS CONCERNED THE CUTS WEREN'T ACCURATE WHICH HAS LED TO THE IMBALANCE HE IS SEEING NOW. WE ARE SUBMITTING THE COMPLAINT TO SEE IF ANYTHING SHOWS UP THAT MIGHT HAVE CAUSED THIS ISSUE. CASE TYPE / APPLICATION: TKA 2.0. MPS: \"THIS SURGEON HAS DONE A MANUAL REVISION ALREADY TO TAKE CARE OF THE PATIENT\"." }, { "mdr_text_key": "390285809", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." }, { "mdr_text_key": "390285810", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING INACCURATE RESECTION INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES NOTED THE FOLLOWING: ROOT CAUSE FOR VALGUS DISCREPANCY IS A FEMORAL BONE REGISTRATION IN WHICH THE INTERCONDYLAR POINTS WERE TAKEN ON THE CONDYLE. THIS ALLOWED THE FEMORAL POINT CLOUD TO SLIDE INTRODUCING ROTATIONAL ERRORS. THERE WAS ALSO A ROTATIONAL ERROR IN THE TIBIAL BONE REGISTRATION. THREE EMINENCE POINTS HAVE A HIGH DISTANCE TO BONE. THE EMINENCE POINTS ARE NOT MAPPED CLOSE TO THE EMINENCE. IT IS LIKELY THAT THE USER CHOSE TO TAKE THESE EMINENCE POINTS MORE DISTALLY ON THE TIBIA INSTEAD OF ON THE EMINENCE AND THE POINT CLOUD SLID PRODUCING A ROTATIONAL ERROR. THE 2ND ROOT CAUSE IS A BASE ARRAY MOTION CAUSING A ROTATIONAL ERROR DURING THE ANTERIOR FEMORAL RESECTION WHICH CAN BE SEEN IN THE BURRLIST REPLAY. THIS WAS NEVER CORRECTED FOR THE REST OF THE CASE LEADING TO A BAD ANTERIOR CHAMFER AND POSTERIOR RESECTIONS. THE POSTERIOR FEMORAL RESECTION WAS DEEP ON THE LATERAL SIDE. ALTHOUGH THESE CUTS DO NOT DIRECTLY AFFECT THE VARUS VALGUS ROTATION IMPLANT FIT WILL INTRODUCE SOME ERROR IN THIS DIRECTION WITH 3 OF THE 5 FEMORAL CUTS INACCURATE. IT IS IMPORTANT TO TAKE THE TOOL AND BONE CHECKPOINTS THROUGHOUT THE CASE WHENEVER THE USER SUSPECTS AN ARRAY MOTION OR WHEN THE BONE RESECTION DOES NOT SEEM TO FIT THE ANATOMY TO CORRECT BONE RESECTION ERROR BEFORE THEY HAPPEN. OTHER CONTRIBUTING FACTORS: THE DISTANCE TO THE ROBOT REGISTRATION CENTER WAS OVER 150 MM FOR ONE RESECTION AND AT OR OVER 200 MM FOR ALL OTHER BONE RESECTION ADDING 1 TO 2MM OF GLOBAL ERROR NOT CUT TO CUT ERROR. DISTAL 195 MM, POSTERIOR CHAMFER 212 MM, ANTERIOR 200 MM, ANTERIOR CHAMFER 172 MM, POSTERIOR 228 MM, TIBIA 194 MM. SIX SUDDEN DISPLACEMENT EVENTS OCCURRED WHILE THE USER IS ENGAGED IN THE STEREOTACTIC, RANGING FROM 2.26MM TO 4.98MM INDICATING THAT THE BASE ARRAY OR CAMERA ARE MOVING. AVOID MOVING THE CAMERA OR ROBOT DURING THE CASE AS THIS CAN CHANGE THE CALIBRATED CUBE SPACE WITH RESPECT TO THE JOINT AND INTRODUCES ADDITIONAL ERROR INTO THE MAKO SYSTEM: 3.21MM DISPLACEMENT DURING DISTAL CUT, 4.98MM DISPLACEMENT DURING POSTERIOR CHAMFER , 2.78MM DISPLACEMENT DURING ANTERIOR CUT, 2.26MM DISPLACEMENT DURING ANTERIOR CHAMFER, 3.97MM DISPLACEMENT DURING POSTERIOR CUT, 3.66MM DISPLACEMENT DURING TIBIA CUT. THE APPLICATION SOFTWARE USES THE MECHANICAL AXIS OF THE FEMUR AND TIBIA TO MEASURE THE VARUS VALGUS ANGLE; THIS REQUIRES A FULL-LENGTH X-RAY FOR A RADIOGRAPHIC COMPARISON. THE VARUS VALGUS ANGLE OF A PARTIAL X-RAY CAN BE MEASURED USING THE CANAL AXIS WHICH REQUIRES A TRUE AP AND NO INTERNAL EXTERNAL ROTATION. THE INTERNAL-EXTERNAL ROTATION CAN REDUCE THE ACCURACY OF THE RADIOGRAPHIC ASSESSMENT. GIVEN THESE DIFFERENCES BETWEEN THE APPLICATION SOFTWARE AND SOURCES OF ERROR IN RADIOGRAPHIC ASSESSMENTS 11° OF VALGUS WAS MEASURED FROM THE X-RAY WHICH IS NOT THE SAME VALUE WHICH WOULD BE DISPLAYED IN IMPLANT PLANNING. THERE IS NO INDICATION OF SYSTEM OR SOFTWARE MALFUNCTION FROM THE SYSTEM LOGS. SERVICE RECORDS INDICATE THAT THE SYSTEM WAS READY FOR CLINICAL USE AND MAINTENANCE ADJUSTED J5 CABLING. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT (B)(6) WAS INSPECTED AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 219999, ROBOT NUMBER: (B)(6) SHOWS NO OTHER SIMILAR COMPLAINTS FOR TKA SOFTWARE - INACCURATE RESECTION. CONCLUSIONS: BASED ON THE ANALYSIS OF THE RELEVANT LOG FILES AND SESSION FILES, THE ALLEGED FAILURE MODE CAN BE CONFIRMED TO HAVE BEEN CAUSED DUE TO USER ERROR. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3365 ENTERPRISE AVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "07430", "manufacturer_contact_exchange": "201", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/19/2025" } ] }