{
  "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": "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": "0009617840-2022-00007",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20220201",
      "manufacturer_address_2": "",
      "pma_pmn_number": "N/A",
      "date_of_event": "20220106",
      "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": "AS",
      "manufacturer_contact_area_code": "574",
      "date_added": "20220202",
      "manufacturer_contact_f_name": "CHRISTINA",
      "device_date_of_manufacturer": "20210521",
      "previous_use_code": "R",
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        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1386343",
          "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": [
        "Incorrect, Inadequate or Imprecise Result or Readings",
        "Incorrect, Inadequate or Imprecise Result or Readings"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250808",
      "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": "13417756",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220107",
      "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": "286673793",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "(B)(4). SAME/ SIMILAR TO 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."
        },
        {
          "mdr_text_key": "286673794",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT WHILE USING THE ROSA PLATFORM DURING A TKA SURGERY, THERE WAS AN OVER RESECTION OF TIBIA BY 3MM. A THICKER THAN EXPECTED POLY IMPLANT HAD TO BE USED. NO ADDITIONAL CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE."
        }
      ],
      "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": ""
    }
  ]
}