{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "NJ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MAHWAH", "manufacturer_contact_address_1": "325 CORPORATE DRIVE", "manufacturer_contact_pcity": "20183150", "event_type": "Injury", "report_number": "0002249697-2023-01171", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20231010", "manufacturer_address_2": "", "pma_pmn_number": "K180612", "date_of_event": "20230915", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "07430", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "2018315000", "noe_summarized": "1", "manufacturer_contact_l_name": "SANTIAGO", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "07430", "manufacturer_g1_state": "NJ", "reporter_country_code": "US", "manufacturer_contact_area_code": "201", "date_added": "20231010", "manufacturer_contact_f_name": "MARISOL", "device_date_of_manufacturer": "20230206", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "302341", "implant_date_year": "2023", "date_removed_year": "2023", "serviced_by_3rd_party_flag": "", "date_received": "20231010", "brand_name": "MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM", "generic_name": "PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM", "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": "180735-1-E", "lot_number": "1P7N3L", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NPJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "07613327386028", "udi_public": "07613327386028", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "RI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/15/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250801", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "2018", "patient": [ { "patient_sequence_number": "1", "date_received": "20231010", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "69 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Pain" ] } ], "distributor_city": "", "date_report": "20231011", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "17907251", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230915", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "07430", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "STRYKER ORTHOPAEDICS-MAHWAH", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "338217628", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PLEASE NOTE MFR REPORT # 0002249697-2023-01171 WAS SUBMITTED UNDER THE INCORRECT FDA REGISTRATION NUMBER, 0002249697 - JR (HOWMEDICA), THEREFORE THIS RECORD IS BEING CLOSED AND NEW INITIAL MDR WILL BE SUBMITTED TO THE CORRECT FDA REGISTRATION NUMBER." }, { "mdr_text_key": "338217629", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REVISED A LEFT MEDIAL TIBIAL INSERT DUE TO A FLOATING LOOSE BODY THAT CAUSED THE PATIENT PAIN. REMOVED THE LOOSE BODY AND PUT A NEW TIBIAL INSERT IN. NO ALLEGATIONS AGAINST THE IMPLANT MADE." }, { "mdr_text_key": "325340311", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REVISED A LEFT MEDIAL TIBIAL INSERT DUE TO A FLOATING LOOSE BODY THAT CAUSED THE PATIENT PAIN. REMOVED THE LOOSE BODY AND PUT A NEW TIBIAL INSERT IN. NO ALLEGATIONS AGAINST THE IMPLANT MADE." }, { "mdr_text_key": "325340312", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING REVISION INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FLOATING LOOSE BODY THAT CAUSED THE PATIENT PAIN. THE EVENT COULD NOT BE CONFIRMED AS INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE RETURN, PRE- AND POST-OPERATIVE X-RAYS, PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. H3 OTHER TEXT : NOT AVAILABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "325 CORPORATE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "07430", "manufacturer_contact_exchange": "201", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/11/2023" } ] }