{ "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": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MRS.", "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": "1818910-2024-21616", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20241015", "manufacturer_address_2": "", "pma_pmn_number": "K202769", "date_of_event": "20241007", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46581", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "3035526892", "noe_summarized": "1", "manufacturer_contact_l_name": "KARBERG", "source_type": [ "Company representation", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "46581", "manufacturer_g1_state": "IN", "reporter_country_code": "US", "manufacturer_contact_area_code": "303", "date_added": "20241015", "manufacturer_contact_f_name": "KATE", "device_date_of_manufacturer": "20220201", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "319725", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20241015", "brand_name": "VELYS BASE STATION", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "DEPUY IRELAND", "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": "451570100", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10603295519515", "udi_public": "(01)10603295519515", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/27/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250808", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "3035", "patient": [ { "patient_sequence_number": "1", "date_received": "20241015", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Limb Fracture", "Unspecified Tissue Injury", "Limb Fracture", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20241015", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "20453078", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241007", "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.", "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": "354201080", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED." }, { "mdr_text_key": "354201081", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE A CUT WAS MADE \"THAT WAS NOT APPROPRIATE\". IT WAS REPORTED THAT WHILE PLACING THE IMPLANT THE ANTERIOR CUT WAS OFF. IT WAS REPORTED THAT A REVISION HAD TO BE MADE TO THE IMPLANT AND THE CONDYLE WAS FRACTURED DURING THE CASE. IT WAS REPORTED THAT THE POINTER HAD NOT BEEN USED FOR VERIFICATION. IT WAS REPORTED THAT THE CUT ON THE FEMUR HAD NOTCHED THE ANTERIOR CORTEX. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A ROBOTIC ASSISTED BASE STATION DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 2 OF 2 FOR (B)(4)." }, { "mdr_text_key": "358360202", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE EVENT LOGS WERE REVIEWED FOR THIS EVENT. THE INVESTIGATION FOUND THAT THE COMPLAINT OF INACCURATE CUTS COULD NOT BE CONFIRMED SINCE THE POINTER TOOL WAS NOT USED TO VERIFY THE RESECTION PLANE. THERE WERE NO DEFECTS FOUND WITH THE SYSTEM OR SOFTWARE. THE INVESTIGATION FOUND THAT THE ROOT CAUSE OF THE COMPLAINT IS LIKELY ARRAY MOVEMENT. WHILE THE ROOT CAUSE OF THE ARRAY MOVEMENT CANNOT BE DETERMINED, THE FAILURE TO SUCCESSFULLY VERIFY THE CHECKPOINT BEFORE CUTS WERE STARTED AND THE FAILURE TO VERIFY THE CHECKPOINT ONCE THE CUTS WERE FOUND TO BE INACCURATE MAKES THIS CASE CAUSE CODE TO BE CAUSE TRACED TO USER." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "700 ORTHOPAEDIC DR.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "46581", "manufacturer_contact_exchange": "303", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/03/2024" } ] }