{
  "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": "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": "0002249697-2021-00872",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20210518",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K150307",
      "date_of_event": "20210423",
      "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",
        "OTHER"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "AS",
      "manufacturer_contact_area_code": "",
      "date_added": "20210518",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "740600",
          "implant_date_year": "2021",
          "date_removed_year": "2021",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20210518",
          "brand_name": "MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 3 - 10 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",
          "expiration_date_of_device": "20250331",
          "model_number": "180733-3",
          "catalog_number": "180733-3",
          "lot_number": "MN1DJ1",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "MBH",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "00848486016463",
          "udi_public": "00848486016463",
          "openfda": {
            "device_name": "Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3565",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Device-Device Incompatibility",
        "Device-Device Incompatibility"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "",
      "date_changed": "20250815",
      "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": "20210518",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " R"
          ],
          "patient_age": "54 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Insufficient Information",
            "Insufficient Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20210518",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "11842177",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210423",
      "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": "251200834",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "REPORTED EVENT:  AN EVENT REGARDING INCORRECT SELECTION INVOLVING MAKO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED.   METHOD & RESULTS:  DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT  DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES.  COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT.  CONCLUSION:  THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED."
        },
        {
          "mdr_text_key": "251200835",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "DURING A MAKO PKA CASE AN INCORRECT SIZE 3 POLY INSERT WAS IMPLANTED ONTO A SIZE 4 TIBIAL BASEPLATE. THE ERROR WAS DISCOVERED BY THE SURGEONS REG AFTER THE PATIENT HAD JUST BEEN CLOSED. THE PATIENT WAS REOPENED AND THE CORRECT SIZE 4 POLY INSERTED. PROBLEM RESOLVED. NO NEW SPINAL OR GA WAS NEEDED."
        }
      ],
      "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": ""
    }
  ]
}