{ "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": "3005985723-2025-00496", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251030", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20220419", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "07430", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "2018315000", "noe_summarized": "1", "manufacturer_contact_l_name": "TALATHI", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "GM", "manufacturer_contact_area_code": "201", "date_added": "20251030", "manufacturer_contact_f_name": "SANJANA", "device_date_of_manufacturer": "20200722", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "642631", "implant_date_year": "2022", "date_removed_year": "2022", "serviced_by_3rd_party_flag": "", "date_received": "20251030", "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": "N", "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", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/25/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260514", "health_professional": "Y", "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": "20251030", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "66 YR", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Deformity/ Disfigurement", "Deformity/ Disfigurement" ] } ], "distributor_city": "", "date_report": "20260318", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "23426704", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251002", "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": "383927276", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "LEGAL DEPARTMENT HAS INFORMED US THAT THE CUSTOMER IS INVOLVED IN A LEGAL DISPUTE IN WHICH IT IS ALLEGED THAT A MAKO DID NOT WORK PROPERLY. ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2022, THE PATIENT, UNDERWENT A KNEE TEP IMPLANTATION USING THE MAKO SYSTEM. THE PREOPERATIVE ANATOMICAL AXIAL DEVIATION SHOWED A VARUS DEFORMITY OF 7° WITH 10° FLEXION. BASED ON THESE FINDINGS, DOCTOR DECIDED TO PERFORM A BONE CUT ON THE TIBIA WITH 1° VARUS AND 0.7° VALGUS, WHICH RESULTED IN A PLANNED TOTAL AXIS CORRECTION OF 0.3° VARUS. AFTER MAKING THE PLANNED INCISIONS ON THE FEMUR AND TIBIA AND INSERTING THE TRIAL IMPLANTS, THE MECHANICAL LEG AXIS WAS MEASURED INTRAOPERATIVELY USING THE MAKO SYSTEM. THE RESULT SHOWED AN AXIS OF 1° VARUS WITH 1° FLEXION. THE ACCURACY OF THE MEASUREMENT WAS CONFIRMED BY THE MPS SYSTEM. THE SURGEON, DID NOT OBJECT TO THE MEASUREMENTS, SO THAT THE FINAL IMPLANTS WERE INSERTED IN ACCORDANCE WITH THE PLANNING. POSTOPERATIVELY, HOWEVER, THE X-RAY CHECK REVEALED AN AXIAL POSITION IN THE VALGUS AREA. TKA 1.0 UPDATE AS PER SALES REP 17-OCT-2025: THE PATIENT UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2022." }, { "mdr_text_key": "401262120", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." }, { "mdr_text_key": "401262121", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING INCORRECT PLACEMENT INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: BASED ON THE ANALYSIS OF THE RELEVANT LOG FILES AND SESSION FILES, THE ALLEGED FAILURE MODE IS CONFIRMED TO BE CAUSED DUE TO USER ERROR. THE ROOT CAUSE OF INACCURATE FEMORAL IMPLANT ALIGNMENT MAY BE ATTRIBUTED TO MULTIFACTORIAL CAUSES, SEE ITEMS LISTED BELOW: 1. THE USER DID NOT FOLLOW THE RECOMMENDED TARGET POINT PATTERN WHICH CAUSED A BONE REGISTRATION FAILURE; INTERCONDYLAR POINTS WERE NOT CAPTURED. TIBIAL TUBEROSITY TARGET POINTS WERE NOT CAPTURED AS DIRECTED BY THE APPLICATION SOFTWARE. ¿THE TIBIAL REGISTRATION REQUIRES USER TO ACQUIRE POINTS ALONG THE TIBIAL TUBEROSITY. 2. HIP CENTER QUALITY METRICS INDICATE A FAILING THE HIP CENTER CAPTURE, WHICH CAUSED A BONE REGISTRATION FAILURE. ¿PIVOT THE LEG ABOUT THE HIP JOINT IN AN EXPANDING SPIRAL MOTION.\" 3. THE TIBIAL AND FEMORAL ARRAY WERE NOT VISIBLE THOUGH OUT THE CASE WHICH INDICATE A SUBOPTIMAL SYSTEM SETUP (E.G., FLEXION VALUE ON JOINT POSITION RECORDED AS N/A) 4. BLUE PROBE IS IN THE CAUTIONARY ZONE AND MAY BE BENT OR DAMAGED. THIS AFFECTS CHECKPOINT ACCURACY AND BONE REGISTRATION ACCURACY. 5. TO ENSURE SYSTEM ACCURACY, USE OF MAKO PARK IS RECOMMENDED. LEG TILT, AND FLEXION WERE NOT IN THE RECOMMENDED RANGES, MAKING SYSTEM SETUP SUBOPTIMAL. OPTIMAL LEG SETUP IS IN THE FOLLOWING RANGES: FLEXION: EXTENSION: 95°-110°, TILT: -6° TO 0°, KNEE HEIGHT: ± 25 MM. MAKO PARK SETUP ENSURES THE CORRECT DISTANCE FROM ROBOT REGISTRATION CENTER AS WELL AS OPTIMAL JOINT ORIENTATION. ADDITIONALLY, PRE-SURGERY CHECKS AND SERVICE RECORD INDICATE THE ROBOTIC ARM WAS READY FOR CLINICAL USE. THERE IS NO INDICATION OF A SYSTEM MALFUNCTION. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. FOR SURE, THE MAKO ROBOT SOFTWARE MUST BE EXAMINED AS TO THE ACCURACY OF ITS PROTOCOL. HAVING SAID THAT, VALGUS DEFORMITY FOLLOWING TOTAL KNEE ARTHROPLASTY, WHETHER ROBOTICALLY ASSISTED OR MANUALLY PERFORMED, IS AN IATROGENIC COMPLICATION. IN MY OPINION, THIS DEGREE OF VALGUS DEFORMITY MOST LIKELY COULD HAVE BEEN RECOGNIZED VISUALLY AT THE TIME OF SURGERY WITH THETRIAL COMPONENTS IN PLACE, ALLOWING THE OPPORTUNITY FOR CORRECTION, EVEN IF MANUAL INSTRUMENTATION HAD TO BE UTILIZED. I WOULD NOT ASSIGN ANY CAUSALITY TO THE PATIENT OR THE IMPLANT ITSELF. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROBOT WAS INSPECTED WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE SHOWS NO OTHER COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED TO BE CAUSED DUE TO USER ERROR: 1. THE USER DID NOT FOLLOW THE RECOMMENDED TARGET POINT PATTERN WHICH CAUSED A BONE REGISTRATION FAILURE; INTERCONDYLAR POINTS WERE NOT CAPTURED. TIBIAL TUBEROSITY TARGET POINTS WERE NOT CAPTURED AS DIRECTED BY THE APPLICATION SOFTWARE. ¿THE TIBIAL REGISTRATION REQUIRES THE USER TO ACQUIRE POINTS ALONG THE TIBIAL TUBEROSITY.\" 2. HIP CENTER QUALITY METRICS INDICATE A FAILING THE HIP CENTER CAPTURE, WHICH CAUSED A BONE REGISTRATION FAILURE. ¿PIVOT THE LEG ABOUT THE HIP JOINT IN AN EXPANDING SPIRAL MOTION.¿ 3. THE TIBIAL AND FEMORAL ARRAY WERE NOT VISIBLE THOUGH OUT THE CASE WHICH INDICATE A SUBOPTIMAL SYSTEM SETUP (E.G., FLEXION VALUE ON JOINT POSITION RECORDED AS N/A) 4. BLUE PROBE IS IN THE CAUTIONARY ZONE AND MAY BE BENT OR DAMAGED. THIS AFFECTS CHECKPOINT ACCURACY AND BONE REGISTRATION ACCURACY. 5. TO ENSURE SYSTEM ACCURACY, USE OF MAKO PARK IS RECOMMENDED. LEG TILT, AND FLEXION WERE NOT IN THE RECOMMENDED RANGES, MAKING SYSTEM SETUP SUBOPTIMAL AS PER THE LABELLING REVIEW: 1. THE TIBIAL REGISTRATION REQUIRES THE USER TO ACQUIRE POINTS ALONG THE TIBIAL TUBEROSITY. THESE POINTS ARE CRITICAL FOR THE SUCCESS OF THE REGISTRATION. IF ACQUIRED INCORRECTLY, IT IS LIKELY THAT INACCURACIES WILL BE INTRODUCED. IN ORDER TO ENSURE PROPER COLLECTION OF THESE POINTS, THE USER IS ADVISED TO ACQUIRE THE POINTS WITH AT LEAST 1 MM OF SPACE BETWEEN THEM AND FORMING A LINE IN THE MEDIAL LATERAL DIRECTION. 2. PIVOT THE LEG ABOUT THE HIP JOINT IN AN EXPANDING SPIRAL MOTION, BUT AVOIDING THE LIMITS OF THE HIP RANGE OF MOTION, UNTIL THE DATA COLLECTION PROGRESS ON SCREEN REACHES 100%. ADDITIONALLY, PRE-SURGERY CHECKS AND SERVICE RECORD INDICATE THE ROBOTIC ARM WAS READY FOR CLINICAL USE. THERE IS NO INDICATION OF A SYSTEM MALFUNCTION. 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": "03/18/2026" } ] }