{
  "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": "2026-08-05",
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    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "*",
      "manufacturer_contact_t_name": "",
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      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "report_number": "1220246-2020-01812",
      "type_of_report": [
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        "Followup"
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      "product_problem_flag": "N",
      "date_received": "20200429",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K142863",
      "date_of_event": "20200406",
      "reprocessed_and_reused_flag": "I",
      "manufacturer_address_1": "",
      "exemption_number": "",
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      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_state": "",
      "reporter_country_code": "GM",
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      "date_added": "20200429",
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      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200429",
          "brand_name": "UNIVERS REVERS GLENO 36 +4 LAT",
          "generic_name": "PHX\tSHOULDER PROSTHESIS, REVERSE CONFIGURATION",
          "manufacturer_d_name": "ARTHREX, INC.",
          "manufacturer_d_address_1": "1370 CREEKSIDE BOULEVARD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "NAPLES",
          "manufacturer_d_state": "FL",
          "manufacturer_d_zip_code": "34108",
          "manufacturer_d_zip_code_ext": "1945",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "341081945",
          "device_operator": "HEALTH PROFESSIONAL",
          "expiration_date_of_device": "20240331",
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          "catalog_number": "AR-9504S-04",
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          "device_availability": "Yes",
          "device_report_product_code": "PHX",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "00888867061408",
          "udi_public": "00888867061408",
          "openfda": {
            "registration_number": [
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            "fei_number": [
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            "device_name": "Shoulder Prosthesis, Reverse Configuration",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3660",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Loosening of Implant Not Related to Bone-Ingrowth"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "04/09/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250808",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20200429",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200507",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10010714",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200409",
      "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": "190334468",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION."
        },
        {
          "mdr_text_key": "190334469",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT A SHOULDER REVISION SURGERY WAS NEEDED AS THE IMPLANT BECAME LOOSE. THE REVISION SURGERY WAS FINISHED SUCCESSFULLY. NO FURTHER INFORMATION PROVIDED. UPDATED INFORMATION OBTAINED 20-APR-2020: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020 AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE REVISION SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER."
        },
        {
          "mdr_text_key": "315492737",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "COMPLAINT NOT CONFIRMED. THE DEVICE WAS RETURNED FREE OF DAMAGE AND WAS FOUND TO MEET DIMENSIONAL SPECIFICATIONS. A POTENTIAL CAUSE OF DISSOCIATION IS IMPROPER AND/OR INCOMPLETE MATING OF THE TAPERLOCK FEATURE DUE TO INTERFERENCE FROM SURROUNDING TISSUE."
        }
      ],
      "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": "05/07/2020"
    }
  ]
}