{ "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": "3005985723-2021-00007", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20210105", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200622", "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": "11544", "implant_date_year": "2020", "date_removed_year": "", "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": [ "Fracture", "Adverse Event Without Identified Device or Use Problem", "Fracture", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/03/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "86 YR", "patient_sex": "", "patient_weight": "48", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Ambulation or Postural Difficulties", "Swelling/ Edema", "Pain", "Ambulation or Postural Difficulties", "Swelling/ Edema" ] } ], "distributor_city": "", "date_report": "20210329", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11120223", "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": "225282628", "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": "225282629", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS REPORTED: \"PT PRESENTED TO EMERGENCY DEPARTMENT W/ COMPLAINT OF PAIN AND SWELLING TO RIGHT LOWER EXTREMITY. XRAY SHOWED PERIHARDWARE FRACTURE AND PT ADMITTED. PT PLACED IN KNEE IMMOBILIZER ON (B)(6) 2020 AND DISCHARGED TO INPATIENT REHAB.\"" }, { "mdr_text_key": "322424798", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED THROUGH 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: A PERIPROSTHETIC DISTAL FEMUR FRACTURE WAS CONFIRMED POSTOPERATIVELY VIA X-RAY REPORTS AND HOSPITAL NOTES. ROOT CAUSE: THE ROOT CAUSE CANNOT BE DETERMINED WITHOUT ADDITIONAL RECORDS AND IN PARTICULAR RADIOGRAPHS. THE QUESTION IS REALLY WHERE EXACTLY DID THE FRACTURE OCCUR? DID IT EXTEND INTO ONE OF THE PIN HOLES FROM THE MAKO, INTO THE BOX CUT, OR INDEPENDENT OF THESE STRESS RISERS. 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 0 SIMILAR COMPLAINTS FOR TKA SOFTWARE - OTHER. CONCLUSIONS: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENT: A PERIPROSTHETIC DISTAL FEMUR FRACTURE WAS CONFIRMED POSTOPERATIVELY VIA X-RAY REPORTS AND HOSPITAL NOTES. THE ROOT CAUSE CANNOT BE DETERMINED WITHOUT ADDITIONAL RECORDS AND IN PARTICULAR RADIOGRAPHS. THE QUESTION IS REALLY WHERE EXACTLY DID THE FRACTURE OCCUR? DID IT EXTEND INTO ONE OF THE PIN HOLES FROM THE MAKO, INTO THE BOX CUT, OR INDEPENDENT OF THESE STRESS RISERS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE CASE SESSION/LOG DATA ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/ OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. H3 OTHER TEXT : DEVICE NOT RETURNED." }, { "mdr_text_key": "322424799", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AS REPORTED: \"PT PRESENTED TO EMERGENCY DEPARTMENT W/ COMPLAINT OF PAIN AND SWELLING TO RIGHT LOWER EXTREMITY. XRAY SHOWED PERIHARDWARE FRACTURE AND PT ADMITTED. PT PLACED IN KNEE IMMOBILIZER ON (B)(6) 2020 AND DISCHARGED TO INPATIENT REHAB.\" UPDATE: \"NONDISPLACED VERTICALLY ORIENTED DISTAL FEMORAL PERIHARDWARE FRACTURE.\"" } ], "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": "03/29/2021" } ] }