{ "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": "3005738134-2016-00010", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20161215", "manufacturer_address_2": "", "pma_pmn_number": "K150307", "date_of_event": "20161129", "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": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20161215", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "825682", "implant_date_year": "2016", "date_removed_year": "2016", "serviced_by_3rd_party_flag": "", "date_received": "20161215", "brand_name": "MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 9 MM", "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", "expiration_date_of_device": "20200930", "model_number": "", "catalog_number": "180735-2", "lot_number": "V63HXL", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NPJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3560", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information", "Off-Label Use", "Insufficient Device Problem Information" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20161215", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "No Known Impact Or Consequence To Patient", "Injury", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20170224", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6178905", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20161129", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Notification" ], "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": "69133758", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "CORRECTED DATA: MANUFACTURING ENTITY AND MANUFACTURING SITE FOR DEVICES IS STRYKER ORTHOPAEDICS-(B)(4). AN EVENT REGARDING INCORRECT SELECTION INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: THE CAUSE OF THE REVISION IN THIS CASE WAS LIKELY DUE TO THE INCORRECT INSERT SELECTION. HOWEVER, FURTHER INFORMATION SUCH AS RETURN OF DEVICE, OPERATIVE REPORTS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED." }, { "mdr_text_key": "69133759", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A SIZE 5X9MM ONLAY TIBIAL INSERT WAS INSERTED ON A SIZE 6 TIBIAL BASE PLATE. UPDATE AS PER SALES RESPONSE RECEIVED ON 09-DEC-2016: \"REASON FOR REVISION WAS: SURGEON PUT A 5X9 POLY ON A SIZE 6 TIBIA BASE PLATE. IT WAS NOT PRODUCT ERROR. THE 5X9MM WAS REMOVED AND A 6X9MM WAS PUT IN PLACE.\"" }, { "mdr_text_key": "62539398", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "62539399", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A SIZE 5X9MM ONLAY TIBIAL INSERT WAS INSERTED ON A SIZE 6 TIBIAL BASE PLATE. UPDATE AS PER SALES RESPONSE RECEIVED ON 09-DEC-2016: \"REASON FOR REVISION WAS: SURGEON PUT A 5X9 POLY ON A SIZE 6 TIBIA BASE PLATE. IT WAS NOT PRODUCT ERROR. THE 5X9MM WAS REMOVED AND A 6X9MM WAS PUT IN PLACE.\"" } ], "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": "02/24/2017" } ] }