{ "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": "3005985723-2015-00245", "type_of_report": [ "" ], "product_problem_flag": "N", "date_received": "20151117", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20151022", "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", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20151117", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "759088", "implant_date_year": "", "date_removed_year": "2015", "serviced_by_3rd_party_flag": "", "date_received": "20151117", "brand_name": "UNKNOWN MAKO PATELLOFEMORAL", "generic_name": "KNEE IMPLANT", "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_MAKO", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "JWH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3560", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20151117", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "97", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Pain", "Injury" ] } ], "distributor_city": "", "date_report": "20151022", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5229138", "removal_correction_number": "", "number_devices_in_event": "", "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": "36364599", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN EVENT REGARDING INFECTION INVOLVING AN UNKNOWN MAKO FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT SUGGESTS A PERIPROSTHETIC INFECTION, WHICH PERSISTED IN A NONCOMPLIANT PATIENT WHO LEFT THE HOSPITAL AGAINST MEDICAL ADVICE AFTER HIS INITIAL SURGERY FOR INFECTION ON (B)(6) 2015. -DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED.. -COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT SUGGESTS A PERIPROSTHETIC INFECTION, WHICH PERSISTED IN A NONCOMPLIANT PATIENT WHO LEFT THE HOSPITAL AGAINST MEDICAL ADVICE AFTER HIS INITIAL SURGERY FOR INFECTION ON (B)(6) 2015. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS NO PATIENT DEMOGRAPHICS, NO PRIMARY OR SECOND REVISION OPERATIVE REPORTS, NO X-RAYS, AND NO EXAMINATION OF EXPLANTED COMPONENTS AND NO RESULTS OF BLOODWORK FOR INFECTION ARE AVAILABLE. 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, THIS INVESTIGATION WILL BE REOPENED." }, { "mdr_text_key": "36364600", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SURGEON REVISED LEFT MAKO KNEE DUE TO PAIN AND INFECTION." }, { "mdr_text_key": "31357570", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: TIBIAL BASEPLATE; CAT# UNKNOWN; LOT# UNKNOWN. PATELLA; CAT# UNKNOWN; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER." }, { "mdr_text_key": "31357571", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SURGEON REVISED LEFT MAKO KNEE DUE TO PAIN AND INFECTION." } ], "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": "" } ] }