{
  "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": "SUITE 3300",
      "event_location": "",
      "report_to_fda": "N",
      "manufacturer_contact_t_name": "MS.",
      "manufacturer_contact_state": "IN",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "MONTREAL, QUEBEC",
      "manufacturer_contact_address_1": "56 E. BELL DR.",
      "manufacturer_contact_pcity": "57452737",
      "event_type": "Injury",
      "report_number": "0009617840-2022-00009",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20220201",
      "manufacturer_address_2": "",
      "pma_pmn_number": "N/A",
      "date_of_event": "20220112",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "46582",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "5745273773",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "ARNT",
      "source_type": [
        "Health Professional",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "H3C 2N6",
      "manufacturer_g1_state": "",
      "reporter_country_code": "SN",
      "manufacturer_contact_area_code": "574",
      "date_added": "20220202",
      "manufacturer_contact_f_name": "CHRISTINA",
      "device_date_of_manufacturer": "20210531",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1378431",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20220201",
          "brand_name": "ROSA RECON PLATFORM 220V",
          "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT",
          "manufacturer_d_name": "ZIMMER CAS",
          "manufacturer_d_address_1": "75 QUEEN STR.",
          "manufacturer_d_address_2": "SUITE 3300",
          "manufacturer_d_city": "MONTREAL, QUEBEC",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "H3C 2",
          "manufacturer_d_zip_code_ext": "N6",
          "manufacturer_d_country": "CA",
          "manufacturer_d_postal_code": "H3C 2N6",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "N/A",
          "catalog_number": "20-8020-100-26",
          "lot_number": "N/A",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "OLO",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "R",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.4560",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Adverse Event Without Identified Device or Use Problem",
        "Adverse Event Without Identified Device or Use Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250807",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "N6",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "5745",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20220201",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20220201",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "CA",
      "manufacturer_contact_city": "WARSAW",
      "mdr_report_key": "13417029",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220115",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "H3C 2",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "ZIMMER CAS",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "284862663",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT FOLLOWING A TKA DONE BY ROSA KNEE SURGICAL INSTRUMENTATION, FEMORAL NOTCHING WAS NOTICED IN THE POST OPERATIVE X-RAYS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED."
        },
        {
          "mdr_text_key": "284862664",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "ZIMMER BIOMET - (B)(4). THIS PRODUCT IS SIMILAR TO PMA/510(K) : K182964. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "75 QUEEN STR.",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "46582",
      "manufacturer_contact_exchange": "574",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}