{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3005985723-2021-00005", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20210105", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200727", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210105", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "12969", "implant_date_year": "2020", "date_removed_year": "2020", "serviced_by_3rd_party_flag": "", "date_received": "20210105", "brand_name": "MAKO ROBOTIC ARM 3.1", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAKO SURGICAL CORP.", "manufacturer_d_address_1": "2555 DAVIE ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "FORT LAUDERDALE", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "33317", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "33317", "device_operator": "HEALTH PROFESSIONAL", "model_number": "219999", "catalog_number": "219999", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "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": [ "Device Dislodged or Dislocated", "Device Dislodged or Dislocated" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/22/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20210105", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "84 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Joint Dislocation", "Joint Dislocation" ] } ], "distributor_city": "", "date_report": "20210415", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11118035", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201214", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "225112729", "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": "225112730", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS REPORTED: \"PT BROUGHT TO EMERGENCY DEPARTMENT DUE TO LEG SWELLING AFTER A FALL AT HOME. OBVIOUS SHORTENING OF LEG NOTED IN EMERGENCY DEPARTMENT, XRAY SHOWED HIP DISLOCATION AND PT ADMITTED. PT RETURN TO OR (B)(6) 2020 FOR HIP REVISION. PT DISCHARGED TO...REHAB.\"" }, { "mdr_text_key": "324890519", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING DISLOCATION INVOLVING A MAKO THA SOFTWARE APPLICATION WAS REPORTED. THE DISLOCATION WAS CONFIRMED THROUGH CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS. METHOD & RESULTS: 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 BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENT: CONFIRMATION: THE EVENT WAS CONFIRMED, THERE WAS A DISLOCATION THAT LED TO REVISION SURGERY. ROOT CAUSE: ADDITIONAL MEDICAL RECORDS AND IN PARTICULAR RADIOGRAPHS WOULD BE REQUIRED TO ASCERTAIN A ROOT CAUSE. BASED ON THE PROVIDED MATERIAL THE DISLOCATION WAS LIKELY THE RESULT OF A COMBINATION OF IMPLANT MAL-POSITION, PATIENT COGNITIVE FACTORS AND/OR TRAUMA. THE ROOT CAUSE DID NOT APPEAR TO BE IMPLANT RELATED. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROB987 WAS INSPECTED ON 30 AUG 2019 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: ROB987 SHOWS 1 SIMILAR COMPLAINTS FOR THA SOFTWARE - OTHER(DISLOCATION). CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED VIA REVIEW OF THE RETURNED MEDICAL RECORDS BY A CLINICIAN HOWEVER THE ROOT CAUSE CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE LOG/SESSION FILES, OPERATIVE REPORTS, PROGRESS NOTES AND X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE." }, { "mdr_text_key": "324890520", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AS REPORTED: \"PT BROUGHT TO EMERGENCY DEPARTMENT DUE TO LEG SWELLING AFTER A FALL AT HOME. OBVIOUS SHORTENING OF LEG NOTED IN EMERGENCY DEPARTMENT, XRAY SHOWED HIP DISLOCATION AND PT ADMITTED. PT RETURN TO OR (B)(6) 2020 FOR HIP REVISION. PT DISCHARGED TO...REHAB.\"" } ], "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": "04/15/2021" } ] }