{
  "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,
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    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "N",
      "manufacturer_contact_t_name": "",
      "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": "3005985723-2026-00336",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20260716",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K242831",
      "date_of_event": "20260623",
      "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": "",
      "date_added": "20260716",
      "manufacturer_contact_f_name": "MARISOL",
      "device_date_of_manufacturer": "20250811",
      "previous_use_code": "I",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1903019",
          "implant_date_year": "2026",
          "date_removed_year": "2026",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260716",
          "brand_name": "MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM",
          "generic_name": "PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER",
          "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": "8H8LE3",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "HRY",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3530",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Adverse Event Without Identified Device or Use Problem"
      ],
      "reporter_state_code": "RI",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260901",
      "health_professional": "Y",
      "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": "20260716",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " R"
          ],
          "patient_age": "78 YR",
          "patient_sex": "Male",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Unspecified Infection"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260716",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "MAHWAH",
      "mdr_report_key": "25837828",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260623",
      "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": "407636821",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION."
        },
        {
          "mdr_text_key": "407636822",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE FOLLOWING INFORMATION WAS PROVIDED: I&D OF RIGHT KNEE WITH MEDIAL UNI POLY SWAP OUT DUE TO INFECTION."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "325 CORPORATE DRIVE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "07430",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}