{ "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": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5165637", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250205", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "UNKNOWN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20250206", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1516414", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250205", "brand_name": "ROSA KNEE SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "ZIMMER CAS", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20250205", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250201", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "21312312", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary 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": "362985573", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(6), A DISTRIBUTORSHIP IN THE SOUTH EAST, FOR ZB CORPORATE. I HAVE OVERHEARD BUSINESS CALLS OF HOW THERE IS A PROBLEM WITH THE SOFTWARE ON THE ROBOTS AND THEY HAVE BEEN MAKING INCORRECT CUTS AND INCORRECT PLACEMENT OF IMPLANTS INTO PATIENTS FOR MONTHS. IT¿S A SYSTEM WIDE PROBLEM NOT JUST A FEW ROBOTS, MANY ROBOTS THEY HAVE OVER THE US ARE MALFUNCTIONING AND THEY HAVE YET TO FIGURE OUT THE EXACT CAUSE. IT¿S GONE AS HIGH UP THE CHAIN AS THE CEO BUT NOTHING IS BEING DONE. THEY HAVEN¿T SHUT DOWN USE. THEY JUST KEEP DOING INCORRECT AND IMMORAL SURGERIES ON PATIENTS AND NOT INFORMING THE DOCTORS THAT THEIR ROBOTS ARE THE REASON FOR THE POOR SURGERIES AND RESULTS. THEY HAVE BEEN TRYING TO FIX THE ISSUE AND COVER IT UP SINCE ZB FIRST BECAME AWARE. AS OF RIGHT NOW IT¿S NOT FIXED AND THEY ARE LETTING SURGEONS CONTINUE TO MAKE HARMFUL, PAINFUL IMPLANTS INTO PATIENTS. THEY¿VE FIRED ANYONE THAT CAME CLOSE TO DISCOVERING THE ISSUE. I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(6), THE DISTRIBUTORSHIP FOR ZIMMER BIOMET IN THE SOUTHEAST DIVISION. THE ROSA ROBOT SOFTWARE HAS BEEN MALFUNCTIONING AND MAKING MISCUTS CONSTANTLY AND CAUSING HARM TO PATIENTS IN SURGERY. THEY HAVE BEEN TRYING TO FIX THE ISSUE BEFORE ANYONE FOUND OUT. THEY'VE FIRED ANYONE THAT CAME CLOSE TO FIGURE IT OUT IN THE PAST 4 MONTHS. I¿VE KNOWN ABOUT IT FOR AT LEAST 6 MONTHS, AND THEY HAVE BEEN DESPERATELY TRYING TO COVER IT UP BEFORE ANY REGULATORY AUTHORITIES FOUND OUT. I WOULD HATE FOR MORE PEOPLE TO CONTINUALLY BE HARMED, UNKNOWINGLY. REF REPORT: MW5165636." } ], "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": "" } ] }