{ "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": "1818910-2024-04395", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20240227", "manufacturer_address_2": "", "pma_pmn_number": "K202769", "date_of_event": "20240126", "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": [ "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "46581", "manufacturer_g1_state": "IN", "reporter_country_code": "US", "manufacturer_contact_area_code": "303", "date_added": "20240227", "manufacturer_contact_f_name": "KATE", "device_date_of_manufacturer": "20230531", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1538283", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20240227", "brand_name": "VELYS SATELLITE 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": "451570101", "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": "10603295519492", "udi_public": "10603295519492", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Malposition of Device", "Complete Loss of Power", "Malposition of Device", "Complete Loss of Power" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/28/2024;*", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250819", "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": "20240227", "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": "20240227", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "18787398", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240222", "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": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "339997584", "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. UPON FOLLOW UP WITH THE REPORTER, ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE THE REPORTER STATED THAT \"OVER RESECTED THE ANTERIOR CUT BY AROUND 20MM. THE CUTS WERE FINISHED MANUALLY. THIS WAS DETECTED RIGHT AWAY WHEN THE CUT WAS MADE. PROCEDURE WAS PLANNED FOR CEMENTED IMPLANTS AND HAD TO CONVERT FEMUR TO A ATTUNE REVISION FEMUR DUE TO THE LARGE ANTERIOR CUT. THE PATIENT OUTCOME WAS GOOD.\" B1, B2: THE ADVERSE EVENT OR PRODUCT PROBLEM UPDATED TO INCLUDE ADVERSE EVENT AND REQUIRED INTERVENTION. UPDATED TO SERIOUS INJURY BASED UPON ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER." }, { "mdr_text_key": "336296237", "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. H10 ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. D10, CONCOMITANT MEDICAL DEVICES AND THERAPY DATES, BASE STATION DEVICE, POWER CORD DEVICE, (B)(6) 2024. UDI: (B)(4)." }, { "mdr_text_key": "336296238", "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 IT WAS NOTICED THAT THE ANTERIOR CUT WAS OFF. IT WAS ALSO REPORTED THAT THE ROBOTIC ASSISTED BASE STATION DEVICE WAS TAKING A LONG TIME TO BOOT UP AND THE POWER CORD WOULD NOT STAY SECURELY ATTACHED TO THE BASE STATION. IT WAS REPORTED THAT THE SYSTEM WAS WORKING HOWEVER THE POWER CORD IS CAUSING FRUSTRATION WITH THE SYSTEM SHUTTING DOWN. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY." }, { "mdr_text_key": "340962912", "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. H10 ADDITIONAL NARRATIVE: THE LOG FILES FOR THIS EVENT HAVE BEEN REVIEWED. THE REVIEW DETERMINED THAT THE POINTER CHECK WAS NOT USED IN ORDER TO VERIFY THE RESECTION PLANE ACCURACY AND CORRECT ANY DEVIATIONS. THE MOST PROBABLE CAUSE FOR THE DESCRIBED ISSUE \"ANTERIOR CUT WAS OFF\" CANNOT BE ESTABLISHED AS THE POINTER WAS NOT UTILIZED AND NO DEFECT WAS FOUND. THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED SINCE NO PROBLEM WAS DETECTED." } ], "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": "03/07/2024;04/19/2024" } ] }