{ "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": "MS.", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "RAHEEN BUSINESS PARK", "manufacturer_contact_pcity": "61498200", "event_type": "Injury", "report_number": "3005985723-2025-00293", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250626", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250604", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "NA", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "61498200", "noe_summarized": "1", "manufacturer_contact_l_name": "RYAN", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "US", "manufacturer_contact_area_code": "614", "date_added": "20250626", "manufacturer_contact_f_name": "ANNA", "device_date_of_manufacturer": "20201218", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "657579", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250626", "brand_name": "MAKO ROBOTIC ARM 3.1", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAKO SURGICAL CORP.", "manufacturer_d_address_1": "3365 ENTERPRISE AVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "WESTON", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "33331", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "33331", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "219999", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "07613327395280", "udi_public": "07613327395280", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Malposition of Device", "Incorrect, Inadequate or Imprecise Result or Readings", "Malposition of Device" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/29/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "EI", "date_changed": "20251120", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6149", "patient": [ { "patient_sequence_number": "1", "date_received": "20250626", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Pain" ] } ], "distributor_city": "", "date_report": "20250825", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "LIMERICK", "mdr_report_key": "22341051", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "33331", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MAKO SURGICAL CORP.", "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": "373574944", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AS ORIGINALLY REPORTED BY MPS: \"PATIENT STARTED WITH 6 DEGREES OF VARUS. MAKO SAID HIS FINAL LIMB ALIGNMENT WAS 1 DEGREE OF VALGUS BUT THE PATIENT IS NOW IN 5 DEGREES OF VALGUS. SURGEON WANTS TO UNDERSTAND WHY. CASE TYPE / APPLICATION: TKA 2.0\" ADDITIONAL INFORMATION: SURGERY ORIGINALLY PERFORMED (B)(6) 2025. ON (B)(6) 2025, MPS WAS MADE AWARE THAT THE PATIENT WAS 'NOW IN 5 DEGREES OF VALGUS' AND THAT THERE WERE PATIENT COMPLAINTS: PATIENT HAS FUNCTIONAL WEAKNESS AND ANKLE/FOOT PAIN." }, { "mdr_text_key": "382950329", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING INACCURATE RESECTION INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS, PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES NOTED THE FOLLOWING: \" THE USER REPORTS THAT THE EXPECTED FINAL LIMB ALIGNMENT WAS 1 DEGREE VALGUS; HOWEVER, THE POST-OPERATIVE ALIGNMENT MEASURED 5 DEGREES VALGUS. UPON REVIEW OF THE SURGICAL WORKFLOW, THERE IS EVIDENCE OF DEEP CUTS IN THE LATERAL COMPARTMENT ON BOTH THE POSTERIOR CHAMFER AND POSTERIOR CUT PLANES. THESE DEEP LATERAL RESECTIONS MAY HAVE CONTRIBUTED TO A VALGUS SHIFT IN OVERALL LIMB ALIGNMENT. WHEN THE LATERAL CUTS ARE DEEPER THAN INTENDED, THE MEDIAL COMPARTMENT MAY SIT PROUD RELATIVE TO THE LATERAL SIDE, WHICH CAN AFFECT HOW THE IMPLANT SEATS ON THE RESECTED FEMUR. THIS DISCREPANCY CAN LEAD TO UNINTENTIONAL VALGUS ALIGNMENT. ON THE X-RAY IMAGE PROVIDED, THE TIBIAL COMPONENT APPEARS TO SLOPE DOWN MEDIALLY. THE APPLICATION WILL DETERMINE LIMB ALIGNMENT RELATIVE TO THE KNEE CENTER IN 3D SPACE INSTEAD OF ESTIMATING BASED ON 2D. THIS MAY FURTHER CONTRIBUTE TO DISCREPANCY BETWEEN COMPARING ALIGNMENT PROVIDED BY TRIALING PAGE AND A MEASUREMENT FROM A RADIOGRAPHIC MEASUREMENT USING ONLY THE KNEE JOINT, AS PROVIDED IN THE X-RAY IMAGE. THE TRIALING PAGE ASSUMES AN IMPLANT POSITION BASED ON A PERFECT SCENARIO. THEREFORE, INACCURACIES IN CUT DEPTH AND IMPLANT SEATING CAN CAUSE ALIGNMENT DEVIATIONS. POTENTIAL SOURCES OF ERROR FOR CUT INACCURACY FROM THIS WORKFLOW CAN BE ATTRIBUTED TO: 1. NOT SEATING ROBOT DURING ROBOT REGISTRATION. 2. DEEP LATERAL POSTERIOR CHAMFER AND POSTERIOR CUTS. 3. FAILURE TO CAPTURE THE INTERCONDYLAR TARGET POINTS ON THE FEMUR. BLADE SKIVING CAN LEAD TO OVERLY DEEP CUTS. THIS CAN BE MITIGATED BY SCORING THE BONE WITH MULTIPLE PASSES. ADDITIONALLY, PERFORMING MEDIAL AND LATERAL RESECTIONS AT DIFFERENT TIMES¿AS WAS DONE IN THIS CASE¿CAN INTRODUCE RELATIVE ERRORS IF THE ARRAY IS BUMPED OR IF THE JOINT OR CAMERA POSITION SHIFTS BETWEEN CUTS. NOTABLY, JOINT POSITION WAS OBSERVED TO CHANGE BETWEEN THE FIRST AND SECOND POSTERIOR CHAMFER RESECTIONS, WHICH MAY HAVE CONTRIBUTED TO CUTTING INCONSISTENCIES. THE CUT SEQUENCE IN THIS WORKFLOW IS NOTED AS: 1. DISTAL (MEDIAL COMPARTMENT). 2. POSTERIOR CHAMFER (MEDIAL COMPARTMENT). 3. DISTAL (LATERAL COMPARTMENT). 4. POSTERIOR CHAMFER (LATERAL COMPARTMENT). 5. POSTERIOR. 6. ANTERIOR. 7. ANTERIOR CHAMFER. 8. TIBIA. FAILURE TO CAPTURE THE INTERCONDYLAR POINT PATTERN ON THE FEMUR CAN CAUSE POINT TO SLIDE EFFECTING THE ORIENTATION OF THE VIRTUAL BONE AND PLAN WITH RESPECT TO THE ACTUAL PATIENT BONE. THERE IS NO INDICATION OF SYSTEM OR SOFTWARE MALFUNCTION. THIS COMPLAINT MAY BE ATTRIBUTED TO A FAILURE TO FOLLOW THE SURGICAL GUIDE, SURGEON'S BONE RESECTION AND IMPLANTATION TECHNIQUE.\" CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT (B)(6) WAS INSPECTED WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N (B)(4), ROBOT NUMBER: (B)(6) SHOWS OTHER SIMILAR COMPLAINTS FOR TKA SOFTWARE - INACCURATE VALUES/VISUALS. CONCLUSIONS: BASED ON THE ANALYSIS OF THE RELEVANT LOG FILES AND SESSION FILES, THE ALLEGED FAILURE MODE CAN BE CONFIRMED TO HAVE BEEN CAUSED BY USER ERROR. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "382950330", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3365 ENTERPRISE AVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "NA", "manufacturer_contact_exchange": "614", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "08/25/2025" } ] }