{
  "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": "0002249697-2018-02287",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20180725",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20180626",
      "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": "20180725",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "561144",
          "implant_date_year": "2011",
          "date_removed_year": "2018",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20180725",
          "brand_name": "RIGHT MEDIAL MAKO ALL POLY TIBIA",
          "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_JR",
          "lot_number": "UNKNOWN",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "JWH",
          "device_age_text": "",
          "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",
        "Insufficient Device Problem Information"
      ],
      "reporter_state_code": "NC",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250812",
      "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": "20180725",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " R"
          ],
          "patient_age": "63 YR",
          "patient_sex": "",
          "patient_weight": "150",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Arthritis",
            "Pain",
            "Injury",
            "Arthritis",
            "Pain",
            "Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20180725",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7717960",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20180626",
      "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": "114954955",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: UNKNOWN RIGHT MEDIAL MAKO FEMORAL COMPONENT; CAT# UNKNOWN; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION."
        },
        {
          "mdr_text_key": "114954956",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT PATIENT'S RIGHT MEDIAL KNEE WAS REVISED TO A PS TOTAL KNEE DUE TO PAIN AND OSTEOARTHRITIS."
        }
      ],
      "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": ""
    }
  ]
}