{
  "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",
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      "manufacturer_contact_zip_ext": "",
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      "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": "0002249697-2022-00430",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20220323",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20200322",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "07430",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "2018315000",
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      "manufacturer_g1_state": "NJ",
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      "manufacturer_contact_area_code": "201",
      "date_added": "20220324",
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          "date_removed_flag": "",
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          "implant_date_year": "2020",
          "date_removed_year": "2020",
          "serviced_by_3rd_party_flag": "",
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          "generic_name": "PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO",
          "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",
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          "manufacturer_d_zip_code_ext": "",
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          "lot_number": "UNKNOWN",
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          "device_report_product_code": "MBH",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "R",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
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            "medical_specialty_description": "Orthopedic",
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        "Adverse Event Without Identified Device or Use Problem"
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      "reporter_state_code": "NJ",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250728",
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          ],
          "sequence_number_outcome": [
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            " R"
          ],
          "patient_age": "",
          "patient_sex": "Male",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Bone Fracture(s)",
            "Bone Fracture(s)"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20220323",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "MAHWAH",
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      "date_manufacturer_received": "20220228",
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      "remedial_action": [
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      ],
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      "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": [
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          "mdr_text_key": "289668033",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
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        },
        {
          "mdr_text_key": "289668034",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2020, A MAKO TOTAL KNEE WITH TRIATHLON WAS IMPLANTED INTO THE PATIENT'S RIGHT KNEE USING PRODUCT/ROBOTIC ASSISTANCE, PINNING THE PRODUCT TO THE PATIENT'S FEMUR. IT IS FURTHER ALLEGED THAT ON OR ABOUT (B)(6) 2020, THE PATIENT'S FEMUR BROKE AS A DIRECT RESULT OF THE PRODUCT AND IMPLANTATION, AND HE UNDERWENT SUBSEQUENT SURGERY AS A RESULT OF HIS INJURIES."
        }
      ],
      "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": ""
    }
  ]
}