{ "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": "MS.", "manufacturer_contact_state": "NJ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "RAHEEN BUSINESS PARK", "manufacturer_contact_pcity": "20183150", "event_type": "Injury", "report_number": "3005985723-2025-00499", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251103", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20251007", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "NA", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "2018315000", "noe_summarized": "1", "manufacturer_contact_l_name": "RYAN", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "US", "manufacturer_contact_area_code": "201", "date_added": "20251103", "manufacturer_contact_f_name": "ANNA", "device_date_of_manufacturer": "20190307", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "169263", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251103", "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", "Adverse Event Without Identified Device or Use Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "ID", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/21/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "EI", "date_changed": "20260312", "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": "20251103", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "60 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unequal Limb Length", "Unequal Limb Length" ] } ], "distributor_city": "", "date_report": "20251217", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "LIMERICK", "mdr_report_key": "23450893", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251007", "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": "395372351", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING LIMB LENGTH DISCREPANCY INVOLVING A MAKO THA SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES NOTED THE FOLLOWING: THE CHANGE IN LEG LENGTH FROM PLAN WAS LESS THAN 2 MM IN REDUCTION RESULTS. THE CHANGE IN LEG LENGTH FROM CONTRALATERAL MAY BE ATTRIBUTED TO THE USER¿S DECISION TO PROCEED WITH A FAILING BONE REGISTRATION. THE USER SHOULD ALSO KEEP IN MIND THE ASSUMPTIONS ASSOCIATED WITH AND EXPRESS WORKFLOW AND MAKO SYSTEM. THE FEMORAL SIDE OF THE TOTAL HIP ARTHROPLASTY IS NOT ROBOTICALLY PREPARED LEADING TO THE FOLLOWING DISCREPANCIES IN LEG LENGTH AND OFFSET: STEM VERSION IS CALCULATED IN THE APPLICATION SOFTWARE USING NO INTERNAL-EXTERNAL ROTATION WITH RESPECT TO THE PELVIC PLANE DEFINED BY THE ASIS AND PUBIC MIDPOINT, FEMUR MECHANICAL AXIS ALIGNMENT OF THE FEMUR POTENTIALLY CHANGING THE LESSER TROCHANTER LOCATION WITH RESPECT TO A POTENTIAL INCORRECT FEMORAL POSITION FOR LANDMARK CAPTURE PREOPERATIVELY AND ON REDUCTION RESULTS. NECK RESECTION LINE AND STEM IMPACTION IS ASSUMED TO FOLLOW IMPLANT PLANNING VALUES AS EXPRESS WORKFLOW PROVIDES NO FEMORAL TRACKING. THE PATIENT POSITION DURING LANDMARK CAPTURE IS NOT ROBOTICALLY CONTROLLED. ¿ALLOW THE REDUCED FEMUR TO REST IN A POSITION WITH THE MECHANICAL AXIS OF THE FEMUR APPROXIMATELY PARALLEL TO THE LONG AXIS OF THE PELVIS AND PATIENT WITH THE KNEE FLEXED APPROXIMATELY 90 DEGREES. THE MECHANICAL STATUS OF THE SYSTEM IS UNKNOWN AS THE USER ONLY PERFORMED ¿HOMING¿ AND DID NOT COMPLETE ALL THE PRE-SURGERY CHECKS. SERVICE RECORD INDICATES THE SYSTEM WAS READY FOR CLINICAL USE. THERE IS NO INDICATION THAT THE APPLICATION SOFTWARE IS NOT PERFORMING CORRECTLY. ANY USER MISINFORMATION PROVIDED TO THE SOFTWARE WILL AFFECT ITS OUTPUT. -CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: \"I CAN CONFIRM THAT THE PATIENT HAD A PRIMARY RIGHT AND LEFT TOTAL HIP ARTHROPLASTY BECAUSE I WAS ABLE TO REVIEW X-RAYS WITH THE IMPLANTS IN PLACE. I CAN ALSO CONFIRM THAT THE PATIENT UNDERWENT REVISION OF THE LEFT TOTAL HIP ARTHROPLASTY IN ORDER TO SHORTEN THE LIMB BECAUSE OF A SIGNIFICANT LEG LENGTH DISCREPANCY POSTOPERATIVELY BECAUSE I WAS ABLE TO REVIEW THE OPERATION REPORT AND THE POST REVISION X-RAYS. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH CERTAINTY. THE CAUSES OF LEG LENGTH DISCREPANCY FOLLOWING TOTAL HIP ARTHROPLASTY ARE MULTI FACTORIAL, INCLUDING SURGICAL TECHNIQUE, PREOPERATIVE PLANNING, AND WHETHER OR NOT THE PREOPERATIVE PLAN WAS EXECUTED CORRECTLY. SINCE ROBOTIC ASSISTANCE WAS UTILIZED, THE ROBOTIC PROTOCOL SHOULD BE ANALYZED TO MAKE SURE THAT THERE WERE NO ERRORS IN EXECUTION OF THE PREOPERATIVE PLAN. I WOULD NOT ASSIGN ANY CAUSALITY TO THE PATIENT OR THE IMPLANTS. ANY AND ALL EXPLANTED PARTS OR PROSTHESES SHOULD BE SUBMITTED TO STRYKER ENGINEERS FOR COMPLETE METALLURGICAL AND/OR MICROSCOPIC EVALUATION AND ANALYSIS.\" -PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT THE ROBOT WAS INSPECTED WITH NO REPORTED DISCREPANCIES -COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS SHOWS NO OTHER SIMILAR COMPLAINTS FOR THA SOFTWARE - LIMB LENGTH DISCREPANCY. CONCLUSIONS: BASED ON THE ANALYSIS OF THE RELEVANT LOG FILES AND SESSION FILES, THE ALLEGED FAILURE MODE CAN BE CONFIRMED TO HAVE BEEN CAUSED BY USER ERROR. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "395372352", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." }, { "mdr_text_key": "384200268", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WE HAD A MAKO RTHA 4.1CASE IN WHICH WE FOLLOWED THE ROBOTIC PLAN TO MATCH THE OTHER SIDE. AFTER THE SURGERY, DOCTOR REPORTED ONE LEG BEING 1.5 CM LONGER THAN THE OTHER. PATIENT WAS EXTREMELY UNHAPPY AND WE HAD TO PROCEED WITH A REVISION. PATIENT HAD LOTS OF SOFT TISSUE ISSUES AND PELVIC ROTATION THAT I THINK WAS THE CONTRIBUTING FACTOR TO THIS DISCREPANCY. HOWEVER, THE COMPLIANCE DEPARTMENT AT THE HOSPITAL WANTS AN OFFICIAL INVESTIGATION DONE INTO THIS CASE TO MAKE SURE THIS WAS NOT A ROBOTIC ERROR. DOCTOR HAS CHANGED HIS WORKFLOW TO ASSESS LEG LENGTHS PRIOR TO SURGERY AND ADJUST OUR ROBOTIC PLAN ACCORDINGLY MOVING FORWARD." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3365 ENTERPRISE AVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "NA", "manufacturer_contact_exchange": "201", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "12/17/2025" } ] }