{ "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": "3005985723-2021-00009", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20210122", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20190520", "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": "20210122", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "109025", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210122", "brand_name": "MAKO ROBOT TKA", "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": "I", "model_number": "", "catalog_number": "UNK_OFL", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Unstable", "Loss of Osseointegration", "Adverse Event Without Identified Device or Use Problem", "Unstable", "Loss of Osseointegration", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "KY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/12/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20210122", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "84 YR", "patient_sex": "", "patient_weight": "86", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Inadequate Osseointegration", "Joint Laxity", "Inadequate Osseointegration", "Joint Laxity" ] } ], "distributor_city": "", "date_report": "20210304", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11214223", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201230", "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": "323319888", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING INSTABILITY (IMPLANT LOOSENING) INVOLVING AN UNKNOWN MAKO ROBOT/TKA APPLICATION SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED THROUGH A CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS HOWEVER THE ROOT CAUSE WAS NOT ESTABLISHED AND AN ALLEGED FAILURE AGAINST THE ROBOT WAS NOT CONFIRMED. 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 INFORMATION BY A CLINICAL CONSULTANT INDICATED: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: ADVERSE EVENT IDENTIFIED PAIN AND MULTIPLE ASPIRATIONS AFTER PRIMARY UNCEMENTED MAKO TKA. REVISION TKA FOR INSTABILITY AND SWELLING. ASPIRATION AND SWELLING POST-OPERATIVELY AFTER REVISION TKA. ONGOING PAIN AFTER TKA REVISION. HAZARDS: THE PCL LAXITY AND ASPIRATIONS WERE NOT A HAZARD RELATIVE TO THE IMPLANTS. THERE MAY HAVE BEEN LOOSENING/FAILURE TO IN-GROW OF THE UNCEMENTED FEMORAL COMPONENT. CONCLUSION OF ASSESSMENT: THE PATIENT HAD AN UNCEMENTED TKA CRUCIATE RETAINING WITH MAKO. MULTIPLE SWELLING EPISODES AND ASPIRATIONS OCCURRED POSTOPERATIVELY. THE KNEE WAS FELT UNSTABLE AND UNDERWENT REVISION. THE STABILITY OF THE FEMORAL IMPLANT WAS NOT DESCRIBED. THE REVISION IMPROVED THE KNEE INSTABILITY. AN ASPIRATION WAS REQUIRED EARLY IN THE POST-OPERATIVE PERIOD FROM THE REVISION. THE KNEE STABILITY WAS IMPROVED BUT THE PATIENT CONTINUED TO HAVE PAIN AND SOME DISSATISFACTION WITH THE KNEE. OTHER THAN THE POTENTIAL FAILURE TO IN-GROW ON THE FEMUR THE ISSUES DID NOT APPEAR TO BE IMPLANT RELATED. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE ROBOT WAS NOT PROPERLY IDENTIFIED. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINT HISTORY RECORDS COULD NOT BE PERFORMED AS THE ROBOT WAS NOT PROPERLY IDENTIFIED. CONCLUSIONS: THE MEDICAL REVIEW CONCLUDED THE PATIENT HAD AN UNCEMENTED TKA CRUCIATE RETAINING WITH MAKO. MULTIPLE SWELLING EPISODES AND ASPIRATIONS OCCURRED POSTOPERATIVELY. THE KNEE WAS FELT UNSTABLE AND UNDERWENT REVISION. THE STABILITY OF THE FEMORAL IMPLANT WAS NOT DESCRIBED. THE REVISION IMPROVED THE KNEE INSTABILITY. AN ASPIRATION WAS REQUIRED EARLY IN THE POST-OPERATIVE PERIOD FROM THE REVISION. THE KNEE STABILITY WAS IMPROVED BUT THE PATIENT CONTINUED TO HAVE PAIN AND SOME DISSATISFACTION WITH THE KNEE. OTHER THAN THE POTENTIAL FAILURE TO IN-GROW ON THE FEMUR THE ISSUES DID NOT APPEAR TO BE IMPLANT RELATED. IN ORDER TO COMPLETE A FULL INVESTIGATION STRYKER WOULD REQUIRE THE RETURN OF THE PATIENT SESSION FILE AND CRISIS LOGS FROM THE PRIMARY SURGERY." }, { "mdr_text_key": "323319889", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "TRIATHLON TRITANIUM IMPLANTED AT INITIAL SX. INSTABILITY LED TO FEMORAL AND INSERT EXCHANGE." }, { "mdr_text_key": "228172228", "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": "228172229", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "TRIATHLON TRITANIUM IMPLANTED AT INITIAL SX. INSTABILITY LED TO FEMORAL AND INSERT EXCHANGE." } ], "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": "03/04/2021" } ] }