{ "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": "0988", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "IN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WARSAW", "manufacturer_contact_address_1": "700 ORTHOPAEDIC DR.", "manufacturer_contact_pcity": "30355268", "event_type": "Injury", "report_number": "1818910-2024-04010", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240222", "manufacturer_address_2": "", "pma_pmn_number": "K202769", "date_of_event": "20240101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46581", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "3035526892", "noe_summarized": "1", "manufacturer_contact_l_name": "KARBERG", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "465810988", "manufacturer_g1_state": "IN", "reporter_country_code": "AS", "manufacturer_contact_area_code": "303", "date_added": "20240222", "manufacturer_contact_f_name": "KATE", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "64998", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20240222", "brand_name": "VELYS SAW BLADE", "generic_name": "INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT", "manufacturer_d_name": "DEPUY IRELAND - 9616671", "manufacturer_d_address_1": "LOUGHBEG RINGASKIDDY CO.", "manufacturer_d_address_2": "", "manufacturer_d_city": "CORK", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "451570000", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10603295519140", "udi_public": "10603295519140", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Unintended Movement", "Unintended Movement" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/16/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250731", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "0988", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "3035", "patient": [ { "patient_sequence_number": "1", "date_received": "20240222", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240222", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "18759467", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240212", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "46581", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "DEPUY ORTHOPAEDICS, INC. 1818910", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "336009168", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "336009169", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHEN VERIFYING THE CUTS ON THE FEMUR, IT APPEARED THAT THE LATERAL POSTERIOR CUT HAD BEEN OVER RESECTED BY 1MM WHEN USING VELYS. WHEN SURGEON PUT TRIALS ON, HE NOTICED CONSIDERABLE 1-2MM GAPS BETWEEN BONE AND TRIAL FEMUR FOR THE: POSTERIOR, ANTERIOR, ANTERIOR CHAMFER AND DISTAL. LEFT TKR USING VELYS ATTUNE PS FB CONSTRUCT." }, { "mdr_text_key": "340246284", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "700 ORTHOPAEDIC DR.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "465810988", "manufacturer_contact_exchange": "303", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/17/2024" } ] }