{ "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", "results": { "skip": 0, "limit": 1, "total": 32652 } }, "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": "0002249697-2020-00802", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200120", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "466059", "implant_date_year": "", "date_removed_year": "2020", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "UNKNOWN LINER", "generic_name": "PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS", "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", "model_number": "", "catalog_number": "UNK_JR", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200512", "device_report_product_code": "LZO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3353", "device_class": "2" } } ], "product_problems": [ "Device Dislodged or Dislocated", "Device Dislodged or Dislocated" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/30/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20200623", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001392", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200330", "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": "189357888", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED." }, { "mdr_text_key": "189357889", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT WAS TAKEN BACK FOR A HIP REVISION BECAUSE OF DISLOCATION. THE HOSPITAL PAPERWORK STATES THAT THE HEAD AND LINER WAS REMOVED WITH NO IMPLANTATION DATE. THERE IS NO ADDITIONAL INFORMATION TO SEND BASED OFF THE HOSPITAL." }, { "mdr_text_key": "317292918", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT AN EVENT REGARDING DISLOCATION INVOLVING AN UNKNOWN IMPLANT LINER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS -PRODUCT EVALUATION AND RESULTS: BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. CONCLUSIONS: BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED." }, { "mdr_text_key": "317292919", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PATIENT WAS TAKEN BACK FOR A HIP REVISION BECAUSE OF DISLOCATION. THE HOSPITAL PAPERWORK STATES THAT THE HEAD AND LINER WAS REMOVED WITH NO IMPLANTATION DATE. THERE IS NO ADDITIONAL INFORMATION TO SEND BASED OFF THE HOSPITAL." } ], "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": "06/23/2020" } ] }