BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANATO STEM SZ 6 RIGHT NEUT

    MDR report key: 5584906 · Received April 18, 2016

    Report

    Report Number
    0002249697-2016-01234
    Event Type
    Malfunction
    Date Received
    April 18, 2016
    Date of Event
    March 22, 2016
    Report Date
    March 22, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K143085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN INTRA-OPERATIVE DISLOCATION INVOLVING AN ANATO STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: BASED ON THE INFORMATION PROVIDED BY THE TREATING SURGEON, THIS EVENT IS NOT DEVICE RELATED BUT RATHER DUE TO PATIENT ANATOMICAL FACTORS. THE SURGEON IMPLANTED THE ANATO STEM BUT DURING THE CLOSED REDUCTION OF THE HIP WITH A TRIAL HEAD COMPONENT, THE JOINT WAS FOUND TO BE UNSTABLE AND A DISLOCATION OCCURRED INTRA-OPERATIVELY. THE SURGEON STATED THAT THE PATIENTS MUSCLES WERE MORE LAX THAN ANTICIPATED AND ELECTED TO REMOVE THE ANATO STEM AND IMPLANT A RESTORATION MODULAR COMPONENT INSTEAD FOR MORE STABILITY. THE SURGEON STATED THAT THE PATIENT¿S ANATOMY REQUIRED ANOTHER STEM TO COMPLETE THE CASE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING A PRIMARY THA, THE SURGEON HAD SUCCESSFULLY IMPLANTED ALL THE FINAL DEVICES WITH THE ASSISTANCE OF THE MAKO ROBOTIC ARM. HE ATTEMPTED TO REDUCE THE HIP WITH A HEAD TRIAL AND FOUND THAT THE HIP WAS UNSTABLE AND THE PATIENT DISLOCATED. THE SURGEON INDICATED THAT THE PATIENT'S MUSCLES WERE LOOSER THAN HE ANTICIPATED. THEREFORE, HE REMOVED THE ANATO STEM AND IMPLANTED A RESTORATION MODULAR STEM TO OFFER MORE STABILITY AND THE CASE WAS COMPLETED SUCCESSFULLY. IT WAS NOTED BY THE SURGEON THAT THE BONE CUTS WERE ACCURATE. HOWEVER, THE PATIENT'S ANATOMY REQUIRED ANOTHER STEM TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    DURING A PRIMARY THA, THE SURGEON HAD SUCCESSFULLY IMPLANTED ALL THE FINAL DEVICES WITH THE ASSISTANCE OF THE MAKO ROBOTIC ARM. HE ATTEMPTED TO REDUCE THE HIP WITH A HEAD TRIAL AND FOUND THAT THE HIP WAS UNSTABLE AND THE PATIENT DISLOCATED. THE SURGEON INDICATED THAT THE PATIENT'S MUSCLES WERE LOOSER THAN HE ANTICIPATED. THEREFORE, HE REMOVED THE ANATO STEM AND IMPLANTED A RESTORATION MODULAR STEM TO OFFER MORE STABILITY AND THE CASE WAS COMPLETED SUCCESSFULLY. IT WAS NOTED BY THE SURGEON THAT THE BONE CUTS WERE ACCURATE. HOWEVER, THE PATIENT'S ANATOMY REQUIRED ANOTHER STEM TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241166 ANATO STEM SZ 6 RIGHT NEUT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 49481605

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other