{ "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": "0002249697-2020-00142", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200120", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20190524", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "CONSUMER", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200120", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "71589", "implant_date_year": "2019", "date_removed_year": "2019", "serviced_by_3rd_party_flag": "", "date_received": "20200120", "brand_name": "UNKNOWN MAKO HIP", "generic_name": "PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED", "manufacturer_d_name": "STRYKER ORTHOPAEDICS-MAHWAH", "manufacturer_d_address_1": "325 CORPORATE DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAHWAH", "manufacturer_d_state": "NJ", "manufacturer_d_zip_code": "07430", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "07430", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK_JR", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LPH", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3358", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "ND", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250822", "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": "20200120", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "113", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Injury", "Unspecified Infection", "Injury" ] } ], "distributor_city": "", "date_report": "20200120", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9608667", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20191223", "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": "188389300", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED." }, { "mdr_text_key": "188389301", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT HAD A RIGHT MAKO THA SURGERY ON (B)(6) 2019. SHE STARTED TO EXPERIENCE DRAINAGE FROM INCISION APPROX. (B)(6) 2019. THE INCISION OPENED ON (B)(6) 2019, PATIENT WENT TO THE ER AND WAS ADMITTED. PATIENT WAS PARTIALLY REVISED ON (B)(6) 2019. PATIENT WAS DISCHARGED A WEEK AFTER REVISION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2019 PATIENT WENT FOR A FOLLOW-UP VISIT AND WAS TOLD TO FOLLOW UP WITH HER ORIGINAL SURGEON. PATIENT WENT TO SEE THE ORIGINAL SURGEON THE SAME DAY AND WAS ADMITTED TO THE HOSPITAL. DURING HER HOSPITAL STAY, MULTIPLE I&DS WERE PERFORMED APPROX. ON (B)(6) 2019, (B)(6) 2019 AND ON (B)(6) 2019. PATIENT WAS DISCHARGED ON (B)(6) 2019. PATIENT CONTINUED TO EXPERIENCE DRAINAGE AFTER BEING DISCHARGED. ALL COMPONENTS WERE REVISED ON (B)(6) 2019 AND A CEMENT SPACER WAS PLACED. ANOTHER I&D WAS PERFORMED ON (B)(6) 2019 AND WAS PLACED IN REHAB. ON (B)(6) 2019 THE SPACER WAS REMOVED, AND PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCT. THIS PI IS FOR REVISION OF 1ST REVISION." } ], "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": "" } ] }