{
  "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": "",
      "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": "0002249697-2022-00054",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20220111",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K180612",
      "date_of_event": "20211215",
      "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": "RAJ",
      "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": "20220111",
      "manufacturer_contact_f_name": "AROKIYA",
      "device_date_of_manufacturer": "20210928",
      "previous_use_code": "I",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "2624219",
          "implant_date_year": "2021",
          "date_removed_year": "2021",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20220111",
          "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": "180735-1-E",
          "catalog_number": "180735-1-E",
          "lot_number": "TT3DLV",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NPJ",
          "device_age_text": "",
          "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": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250821",
      "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": "20220111",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " R"
          ],
          "patient_age": "62 YR",
          "patient_sex": "Male",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Unspecified Infection",
            "Unspecified Infection"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20220111",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "MAHWAH",
      "mdr_report_key": "13221431",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20211215",
      "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": "285728817",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 4; CAT#:180514 ; LOT#: 3HB5-1. MCK TIBIAL BASEPLATE-RM/LL-SZ 5; CAT#:180615 ; LOT#: 0000951218. SIMPLEX HV US 1 PACK; CAT#: 6194-1-001 ; LOT#: 110AA903JB. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE."
        },
        {
          "mdr_text_key": "285728818",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "DR. PERFORMED AN I&D AND REVISED A MAKO TIBIAL INSERT THAT WAS ORIGINALLY DONE BY DR. ON (B)(6) 2021 DUE TO INFECTION. RIGHT KNEE."
        }
      ],
      "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": ""
    }
  ]
}