BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8946467 · Received August 29, 2019

    Report

    Report Number
    3005985723-2019-00606
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 14, 2019
    Report Date
    March 9, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING PERIPROSTHETIC FRACTURE OF THE PATIENTS ACETABULUM INVOLVING 3.0 RIO® ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. IT WAS REPORTED THAT THE ¿PATIENT HAD A COMPETITOR NAIL IN HER LEFT FEMUR WHICH WAS REVISED TO A STRYKER TOTAL HIP WITH ROBOT NAVIGATION ON (B)(6) 2019. ON (B)(6) 2019, IT WAS DISCOVERED THAT THE PATIENT'S ACETABULUM HAD FRACTURED AT THE POSTERIOR WALL AND POSTERIOR COLUMN. ON (B)(6) 2019, THE SURGEON REVISED THE SHELL, 36D 0° POLY LINER, AND BIOLOX 36 +0 HEAD TO A NEW SHELL WITH AN ADM/ MDM LINER CONSTRUCT AND ANOTHER FEMORAL HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE LINER OR FEMORAL HEAD. THE RESTORATION MODULAR 23 +0 BODY HAD BEEN REMOVED TO ACCESS THE PATIENT'S ACETABULUM, AND RE-IMPLANTED. POSSIBLE CAUSE OR TIME OF FRACTURE ARE UNKNOWN (OR WHETHER IT WAS PRE- OR POST- MAKO PROCEDURE), BUT DURING THE IMPLANTATION (B)(6) 2019, THE SURGEON REPORTED THAT THE SHELL FELT "INCREDIBLY STABLE" AND SAW NO NEED TO IMPLANT SUPPLEMENTAL SCREWS. REP PROVIDED THE PRIMARY USAGE SHEET AND EXPLANT PICTURES, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.¿. PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS CASE SESSION DATA WAS NOT PROVIDED. -CLINICIAN REVIEW: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED FOR REVIEW. PRODUCT HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORDS ASSOCIATED WITH RIO 281 INDICATE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW. A SEARCH OF THE COMPLAINT DATABASE UNDER DEVICE IDENTIFICATION PN 209999 REPORTS NO SIMILAR COMPLAINTS FOR THA SOFTWARE - OTHER. CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS NO CASE SESSION DATA OR LOGS WERE PROVIDED AFTER THREE COMMUNICATION ATTEMPTS WERE MADE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED SUCH AS THE SESSION FILES, THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A SEARCH OF THE NC/CAPA DATABASE UNDER DEVICE IDENTIFICATION PN 209999 REPORTS NO RECORDS RELATED TO THA SOFTWARE - OTHER.

    Description of Event or Problem · 0

    THIS PI IS FOR THE ROBOT USED IN THE PRIMARY IMPLANTATION OF STRYKER DEVICES ON (B)(6) 2019. PATIENT HAD A COMPETITOR NAIL IN HER LEFT FEMUR WHICH WAS REVISED TO A STRYKER TOTAL HIP WITH ROBOT NAVIGATION ON (B)(6) 2019. ON (B)(6) 2019, IT WAS DISCOVERED THAT THE PATIENT'S ACETABULUM HAD FRACTURED AT THE POSTERIOR WALL AND POSTERIOR COLUMN. ON (B)(6) 2019, THE SURGEON REVISED THE SHELL, 36D 0° POLY LINER, AND BIOLOX 36 +0 HEAD TO A NEW SHELL WITH AN ADM/ MDM LINER CONSTRUCT AND ANOTHER FEMORAL HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE LINER OR FEMORAL HEAD. THE RESTORATION MODULAR 23 +0 BODY HAD BEEN REMOVED TO ACCESS THE PATIENT'S ACETABULUM, AND RE-IMPLANTED. POSSIBLE CAUSE OR TIME OF FRACTURE ARE UNKNOWN (OR WHETHER IT WAS PRE- OR POST- MAKO PROCEDURE), BUT DURING THE IMPLANTATION (B)(6) 2019, THE SURGEON REPORTED THAT THE SHELL FELT "INCREDIBLY STABLE" AND SAW NO NEED TO IMPLANT SUPPLEMENTAL SCREWS. REP PROVIDED THE PRIMARY USAGE SHEET AND EXPLANT PICTURES, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Additional Manufacturer Narrative · 1

    AS PART OF THE NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS PI IS FOR THE ROBOT USED IN THE PRIMARY IMPLANTATION OF STRYKER DEVICES ON (B)(6) 2019. PATIENT HAD A COMPETITOR NAIL IN HER LEFT FEMUR WHICH WAS REVISED TO A STRYKER TOTAL HIP WITH ROBOT NAVIGATION ON (B)(6) 2019. ON (B)(6) 2019, IT WAS DISCOVERED THAT THE PATIENT'S ACETABULUM HAD FRACTURED AT THE POSTERIOR WALL AND POSTERIOR COLUMN. ON (B)(6) 2019, THE SURGEON REVISED THE SHELL, 36D 0° POLY LINER, AND BIOLOX 36 +0 HEAD TO A NEW SHELL WITH AN ADM/ MDM LINER CONSTRUCT AND ANOTHER FEMORAL HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE LINER OR FEMORAL HEAD. THE RESTORATION MODULAR 23 +0 BODY HAD BEEN REMOVED TO ACCESS THE PATIENT'S ACETABULUM, AND RE-IMPLANTED. POSSIBLE CAUSE OR TIME OF FRACTURE ARE UNKNOWN (OR WHETHER IT WAS PRE- OR POST- MAKO PROCEDURE), BUT DURING THE IMPLANTATION (B)(6) 2019, THE SURGEON REPORTED THAT THE SHELL FELT "INCREDIBLY STABLE" AND SAW NO NEED TO IMPLANT SUPPLEMENTAL SCREWS. REP PROVIDED THE PRIMARY USAGE SHEET AND EXPLANT PICTURES, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739779 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209999 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other