BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9333789 · Received November 18, 2019

    Report

    Report Number
    3012916784-2019-00021
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    November 5, 2019
    Report Date
    November 18, 2019
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT. PATIENT EXPERIENCED DISLOCATION APPROXIMATELY 1 YEAR FOLLOWING PRIMARY SURGERY. THE PATIENT RECEIVED THE USE OF OPS PLAN ((B)(4)), PSV, DHA AND THE ACETABULAR GUIDE IN THE PRIMARY SURGERY. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT ((B)(4)) WHICH ALSO EMPLOYS THE USE OF THESE FUNCTIONAL X-RAYS IS CLEARED BY THE FDA. THE ACHIEVED ACETABULAR CUP POSITIONING WAS DETERMINED TO DIFFER SIGNIFICANTLY FROM THE PLANNED ACETABULAR CUP POSITIONING, HOWEVER THE SURGEON WAS CONFIRMED TO HAVE USED THE ACETABULAR GUIDE AS INTENDED DURING THE PRIMARY 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. THE MANUFACTURER HAS CONDUCTED A ROOT CAUSE INVESTIGATION INTO THIS EVENT. THE PROCESSING OF THE PRE-OPERATIVE PLANNING PROVIDED TO THE PRIMARY SURGERY WAS REVIEWED. IT WAS FOUND THAT ALL PROCESSING WAS COMPLETED WITHIN MANUFACTURING SPECIFICATION. THE SURGEON MADE ADDITIONAL COMMENTS THAT THEY BELIEVED THE DISLOCATION WAS DUE TO UNUSUAL PATIENT ANATOMY, AS SUGGESTED BY OFFSET AND LEG LENGTH VALUES MEASURED IN THE PRE-OPERATIVE PLANNING. THE SURGEON STATED THAT BY THEIR ASSESSMENT THE DISLOCATION WAS THE RESULT OF UNFAVOURABLE JOINT MECHANICS, THE PATIENT HAVING VERY LONG LEGS, AND THE PATIENT GETTING INTO UNFAVOURABLE POSITIONS NOT RECOMMENDED POST HIP REPLACEMENT (I.E. BENDING DOWN TOO LOW). PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AND ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    (B)(4) FINAL REPORT. PATIENT EXPERIENCED DISLOCATION APPROXIMATELY 1 YEAR FOLLOWING PRIMARY SURGERY. THE PATIENT RECEIVED THE USE OF OPS PLAN ((B)(4)), PSV, DHA AND THE ACETABULAR GUIDE IN THE PRIMARY SURGERY. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT ((B)(4)) WHICH ALSO EMPLOYS THE USE OF THESE FUNCTIONAL X-RAYS IS CLEARED BY THE FDA. THE ACHIEVED ACETABULAR CUP POSITIONING WAS DETERMINED TO DIFFER SIGNIFICANTLY FROM THE PLANNED ACETABULAR CUP POSITIONING, HOWEVER THE SURGEON WAS CONFIRMED TO HAVE USED THE ACETABULAR GUIDE AS INTENDED DURING THE PRIMARY 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. THE MANUFACTURER HAS CONDUCTED A ROOT CAUSE INVESTIGATION INTO THIS EVENT. THE PROCESSING OF THE PRE-OPERATIVE PLANNING PROVIDED TO THE PRIMARY SURGERY WAS REVIEWED. IT WAS FOUND THAT ALL PROCESSING WAS COMPLETED WITHIN MANUFACTURING SPECIFICATION. THE SURGEON MADE ADDITIONAL COMMENTS THAT THEY BELIEVED THE DISLOCATION WAS DUE TO UNUSUAL PATIENT ANATOMY, AS SUGGESTED BY OFFSET AND LEG LENGTH VALUES MEASURED IN THE PRE-OPERATIVE PLANNING. THE SURGEON STATED THAT BY THEIR ASSESSMENT THE DISLOCATION WAS THE RESULT OF UNFAVOURABLE JOINT MECHANICS, THE PATIENT HAVING VERY LONG LEGS, AND THE PATIENT GETTING INTO UNFAVOURABLE POSITIONS NOT RECOMMENDED POST HIP REPLACEMENT (I.E. BENDING DOWN TOO LOW).

    Additional Manufacturer Narrative · 1

    CC-371 INITIAL REPORT PATIENT EXPERIENCED DISLOCATION APPROXIMATELY 1 YEAR FOLLOWING PRIMARY SURGERY. THE PATIENT RECEIVED THE USE OF OPS PLAN, PSV, DHA AND THE ACETABULAR GUIDE IN THE PRIMARY SURGERY. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) WHICH ALSO EMPLOYS THE USE OF THESE FUNCTIONAL X-RAYS IS CLEARED BY THE FDA. THE ACHIEVED ACETABULAR CUP POSITIONING WAS DETERMINED TO DIFFER SIGNIFICANTLY FROM THE PLANNED ACETABULAR CUP POSITIONING, HOWEVER THE SURGEON WAS CONFIRMED TO HAVE USED THE ACETABULAR GUIDE AS INTENDED DURING THE PRIMARY 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. PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AND ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    CC-371 INITIAL REPORT PATIENT EXPERIENCED DISLOCATION APPROXIMATELY 1 YEAR FOLLOWING PRIMARY SURGERY. THE PATIENT RECEIVED THE USE OF OPS PLAN, PSV, DHA AND THE ACETABULAR GUIDE IN THE PRIMARY SURGERY. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) WHICH ALSO EMPLOYS THE USE OF THESE FUNCTIONAL X-RAYS IS CLEARED BY THE FDA. THE ACHIEVED ACETABULAR CUP POSITIONING WAS DETERMINED TO DIFFER SIGNIFICANTLY FROM THE PLANNED ACETABULAR CUP POSITIONING, HOWEVER THE SURGEON WAS CONFIRMED TO HAVE USED THE ACETABULAR GUIDE AS INTENDED DURING THE PRIMARY 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131226 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 AND_MO_13864

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention