BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9589641 · Received January 14, 2020

    Report

    Report Number
    3012916784-2020-00044
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    December 6, 2019
    Report Date
    February 12, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT RECEIVED LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2018, FOLLOWED BY RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2018. APPROXIMATELY ON (B)(6) 2019, THE PATIENT EXPERIENCED POSTERIOR DISLOCATION OF THE RIGHT HIP. THE PATIENT RECEIVED THE USE OF THE ACETABULAR GUIDE (K152893), FEMORAL GUIDE (K181061), OPS PLAN, DHA AND PSV AT THE PRIMARY SURGERY. THE PRE-OPERATIVE IMAGING FOR THIS PATIENT WAS REVIEWED BY OPTIMIZED ORTHO'S CHIEF MEDICAL OFFICER, AND IT WAS FOUND THAT THE PATIENT WOULD EXPERIENCE ANTERIOR IMPINGEMENT OF THE ACETABULAR CUP FOLLOWING SURGERY AND THAT THE PATIENT WAS A POSTERIOR ROTATOR IN ALL FUNCTIONAL POSITIONS, DRIVEN BY THE OTHER HIP ALREADY HAVING BEEN REPLACED. THE CHIEF MEDICAL OFFICER DETERMINED THAT THIS WOULD SUGGEST THAT THE DISLOCATION WOULD BE ANTERIOR RATHER THAN POSTERIOR. TO FURTHER LOOK INTO THE HIP MECHANICS OF THE PATIENT, POST-OPERATIVE X-RAYS AND CT IMAGING WAS REQUESTED FROM THE SURGEON REPRESENTATIVE. THIS PATIENT HAS NOT BEEN REPORTED TO HAVE A REVISION. A ROOT CAUSE INVESTIGATION HAS NOW BEEN CONDUCTED INTO THIS EVENT. THE PRE-OPERATIVE PLANNING PROVIDED TO THE PRIMARY SURGERY WAS REVIEWED AS PART OF THIS INVESTIGATION. IT WAS CONFIRMED THAT ALL OPERATIONS ASSOCIATED WITH CREATING THIS PLANNING WERE PERFORMED CORRECTLY. THE SURGEON REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION NOTING THAT "THE PATIENT HAD PUT HERSELF INTO AN UNNATURAL POSITION TO PUT ON HER SHOES" AND THAT DURING THE PRIMARY SURGERY THE SURGEON "ADDED MORE ANTEVERSION TO THE STEM ON PURPOSE" COMPARED TO THE PLANNED STEM ANTEVERSION. IT WAS DETERMINED THAT THIS REPORTEDLY UNNATURAL POSITION MAY HAVE CONTRIBUTED TO THIS EVENT. THERE WAS NO EVIDENCE TO SUGGEST THAT THE OPS TECHNOLOGY PROVIDED TO THE PRIMARY SURGERY MALFUNCTIONED OR WAS DEFICIENT. DISLOCATION IS A KNOWN COMPLICATION FOLLOWING HIP SURGERY. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 0

    PATIENT RECEIVED LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2018, FOLLOWED BY RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2018. APPROXIMATELY ON (B)(6) 2019, THE PATIENT EXPERIENCED POSTERIOR DISLOCATION OF THE RIGHT HIP. THE PATIENT RECEIVED THE USE OF THE ACETABULAR GUIDE (K152893), FEMORAL GUIDE (K181061), OPS PLAN, DHA AND PSV AT THE PRIMARY SURGERY. THE PRE-OPERATIVE IMAGING FOR THIS PATIENT WAS REVIEWED BY OPTIMIZED ORTHO'S CHIEF MEDICAL OFFICER, AND IT WAS FOUND THAT THE PATIENT WOULD EXPERIENCE ANTERIOR IMPINGEMENT OF THE ACETABULAR CUP FOLLOWING SURGERY AND THAT THE PATIENT WAS A POSTERIOR ROTATOR IN ALL FUNCTIONAL POSITIONS, DRIVEN BY THE OTHER HIP ALREADY HAVING BEEN REPLACED. THE CHIEF MEDICAL OFFICER DETERMINED THAT THIS WOULD SUGGEST THAT THE DISLOCATION WOULD BE ANTERIOR RATHER THAN POSTERIOR. TO FURTHER LOOK INTO THE HIP MECHANICS OF THE PATIENT, POST-OPERATIVE X-RAYS AND CT IMAGING WAS REQUESTED FROM THE SURGEON REPRESENTATIVE. THIS PATIENT HAS NOT BEEN REPORTED TO HAVE A REVISION. A ROOT CAUSE INVESTIGATION HAS NOW BEEN CONDUCTED INTO THIS EVENT. THE PRE-OPERATIVE PLANNING PROVIDED TO THE PRIMARY SURGERY WAS REVIEWED AS PART OF THIS INVESTIGATION. IT WAS CONFIRMED THAT ALL OPERATIONS ASSOCIATED WITH CREATING THIS PLANNING WERE PERFORMED CORRECTLY. THE SURGEON REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION NOTING THAT "THE PATIENT HAD PUT HERSELF INTO AN UNNATURAL POSITION TO PUT ON HER SHOES" AND THAT DURING THE PRIMARY SURGERY THE SURGEON "ADDED MORE ANTEVERSION TO THE STEM ON PURPOSE" COMPARED TO THE PLANNED STEM ANTEVERSION. IT WAS DETERMINED THAT THIS REPORTEDLY UNNATURAL POSITION MAY HAVE CONTRIBUTED TO THIS EVENT. THERE WAS NO EVIDENCE TO SUGGEST THAT THE OPS TECHNOLOGY PROVIDED TO THE PRIMARY SURGERY MALFUNCTIONED OR WAS DEFICIENT. DISLOCATION IS A KNOWN COMPLICATION FOLLOWING HIP SURGERY. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Additional Manufacturer Narrative · 1

    PATIENT RECEIVED LEFT TOTAL HIP ARTHROPLASTY IN (B)(6) 2018, FOLLOWED BY RIGHT TOTAL HIP ARTHROPLASTY IN (B)(6) 2018. APPROXIMATELY (B)(6) 2019, THE PATIENT EXPERIENCED POSTERIOR DISLOCATION OF THE RIGHT HIP. THE PATIENT RECEIVED THE USE OF THE ACETABULAR GUIDE (K152893), FEMORAL GUIDE (K181061), OPS PLAN, DHA AND PSV AT THE PRIMARY SURGERY. THE PRE-OPERATIVE IMAGING FOR THIS PATIENT WAS REVIEWED BY OPTIMIZED ORTHO'S CHIEF MEDICAL OFFICER, AND IT WAS FOUND THAT THE PATIENT WOULD EXPERIENCE ANTERIOR IMPINGEMENT OF THE ACETABULAR CUP FOLLOWING SURGERY AND THAT THE PATIENT WAS A POSTERIOR ROTATOR IN ALL FUNCTIONAL POSITIONS, DRIVEN BY THE OTHER HIP ALREADY HAVING BEEN REPLACED. THE CHIEF MEDICAL OFFICER DETERMINED THAT THIS WOULD SUGGEST THAT THE DISLOCATION WOULD BE ANTERIOR RATHER THAN POSTERIOR. TO FURTHER LOOK INTO THE HIP MECHANICS OF THE PATIENT, POST-OPERATIVE X-RAYS AND CT IMAGING WAS REQUESTED FROM THE SURGEON REPRESENTATIVE. THIS PATIENT HAS NOT BEEN REPORTED TO HAVE A REVISION. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    PATIENT RECEIVED LEFT TOTAL HIP ARTHROPLASTY IN (B)(6) 2018, FOLLOWED BY RIGHT TOTAL HIP ARTHROPLASTY IN (B)(6) 2018. APPROXIMATELY DECEMBER 2019, THE PATIENT EXPERIENCED POSTERIOR DISLOCATION OF THE RIGHT HIP. THE PATIENT RECEIVED THE USE OF THE ACETABULAR GUIDE (K152893), FEMORAL GUIDE (K181061), OPS PLAN, DHA AND PSV AT THE PRIMARY SURGERY. THE PRE-OPERATIVE IMAGING FOR THIS PATIENT WAS REVIEWED BY OPTIMIZED ORTHO'S CHIEF MEDICAL OFFICER, AND IT WAS FOUND THAT THE PATIENT WOULD EXPERIENCE ANTERIOR IMPINGEMENT OF THE ACETABULAR CUP FOLLOWING SURGERY AND THAT THE PATIENT WAS A POSTERIOR ROTATOR IN ALL FUNCTIONAL POSITIONS, DRIVEN BY THE OTHER HIP ALREADY HAVING BEEN REPLACED. THE CHIEF MEDICAL OFFICER DETERMINED THAT THIS WOULD SUGGEST THAT THE DISLOCATION WOULD BE ANTERIOR RATHER THAN POSTERIOR. TO FURTHER LOOK INTO THE HIP MECHANICS OF THE PATIENT, POST-OPERATIVE X-RAYS AND CT IMAGING WAS REQUESTED FROM THE SURGEON REPRESENTATIVE. THIS PATIENT HAS NOT BEEN REPORTED TO HAVE A REVISION. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48750 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 BRA_UD_13816

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR