BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9399603 · Received December 2, 2019

    Report

    Report Number
    3012916784-2019-00025
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    October 18, 2019
    Report Date
    January 7, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT UNDERWENT A THA PROCEDURE WHERE THE FOLLOWING ASSISTIVE TECHNOLOGY WERE USED; PATIENT SPECIFIC ACETABULAR GUIDE (K152893), THE PATIENT SPECIFIC FEMORAL GUIDE (K181061), THE OPS PLAN REPORT (K183038), THE PATIENT SPECIFIC VISUALISATION (PSV) REPORT (K152893), AND THE DYNAMIC HIP ANALYSIS (DHA) REPORT. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K190834) WHICH ALSO EMPLOYS THE USE OF FUNCTIONAL X-RAYS IS CLEARED BY THE FDA. THE PATIENT DISLOCATED IN REHAB PRIOR TO BEING DISCHARGED, AND AGAIN APPROXIMATELY 1 WEEK POST OP. IT WAS REPORTED THAT THE PATIENT HAS A PRE-EXISTING NEUROLOGICAL CONDITION THAT MADE THEM A FALLS RISK. THE SURGEON WHO PERFORMED THE PRIMARY AND REVISION SURGERIES CONFIRMED THAT HE BELIEVED THESE DISLOCATIONS TO BE THE RESULT OF THE PATIENT'S NEUROLOGICAL CONDITION. THE MANUFACTURER CONDUCTED A ROOT CAUSE INVESTIGATION INTO THIS EVENT. THIS INVESTIGATION DID NOT FIND ANY ISSUE WITH THE PROCESSING OF THE CASE, AND ALL PRODUCTS PROVIDED TO THE SURGEON FOR USE IN THE PRIMARY SURGERY WERE CONFIRMED TO HAVE BEEN MANUFACTURED ACCORDING TO SPECIFICATION. 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 · 0

    PATIENT UNDERWENT A THA PROCEDURE WHERE THE FOLLOWING ASSISTIVE TECHNOLOGY WERE USED; PATIENT SPECIFIC ACETABULAR GUIDE (K152893), THE PATIENT SPECIFIC FEMORAL GUIDE (K181061), THE OPS PLAN REPORT (K183038), THE PATIENT SPECIFIC VISUALISATION (PSV) REPORT (K152893), AND THE DYNAMIC HIP ANALYSIS (DHA) REPORT. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K190834) WHICH ALSO EMPLOYS THE USE OF FUNCTIONAL X-RAYS IS CLEARED BY THE FDA. THE PATIENT DISLOCATED IN REHAB PRIOR TO BEING DISCHARGED, AND AGAIN APPROXIMATELY 1 WEEK POST OP. IT WAS REPORTED THAT THE PATIENT HAS A PRE-EXISTING NEUROLOGICAL CONDITION THAT MADE THEM A FALLS RISK. THE SURGEON WHO PERFORMED THE PRIMARY AND REVISION SURGERIES CONFIRMED THAT HE BELIEVED THESE DISLOCATIONS TO BE THE RESULT OF THE PATIENT'S NEUROLOGICAL CONDITION. THE MANUFACTURER CONDUCTED A ROOT CAUSE INVESTIGATION INTO THIS EVENT. THIS INVESTIGATION DID NOT FIND ANY ISSUE WITH THE PROCESSING OF THE CASE, AND ALL PRODUCTS PROVIDED TO THE SURGEON FOR USE IN THE PRIMARY SURGERY WERE CONFIRMED TO HAVE BEEN MANUFACTURED ACCORDING TO SPECIFICATION. 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 UNDERWENT A THA PROCEDURE WHERE THE FOLLOWING ASSISTIVE TECHNOLOGY WERE USED; PATIENT SPECIFIC ACETABULAR GUIDE (K152893), THE PATIENT SPECIFIC FEMORAL GUIDE (K181061), THE OPS PLAN REPORT (K183038), THE PATIENT SPECIFIC VISUALISATION (PSV) REPORT (K152893), AND THE DYNAMIC HIP ANALYSIS (DHA) REPORT. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K190834) WHICH ALSO EMPLOYS THE USE OF FUNCTIONAL X-RAYS IS CLEARED BY THE FDA. THE PATIENT DISLOCATED IN REHAB PRIOR TO BEING DISCHARGED, AND AGAIN APPROXIMATELY 1 WEEK POST OP. IT WAS REPORTED THAT THE PATIENT HAS A PRE-EXISTING NEUROLOGICAL CONDITION THAT MADE THEM A FALLS RISK. THE SURGEON WHO PERFORMED THE PRIMARY AND REVISION SURGERIES CONFIRMED THAT HE BELIEVED THESE DISLOCATIONS TO BE THE RESULT OF THE PATIENT'S NEUROLOGICAL CONDITION. 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 UNDERWENT A THA PROCEDURE WHERE THE FOLLOWING ASSISTIVE TECHNOLOGY WERE USED; PATIENT SPECIFIC ACETABULAR GUIDE (K152893), THE PATIENT SPECIFIC FEMORAL GUIDE (K181061), THE OPS PLAN REPORT (K183038), THE PATIENT SPECIFIC VISUALISATION (PSV) REPORT (K152893), AND THE DYNAMIC HIP ANALYSIS (DHA) REPORT. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K190834) WHICH ALSO EMPLOYS THE USE OF FUNCTIONAL X-RAYS IS CLEARED BY THE FDA. THE PATIENT DISLOCATED IN REHAB PRIOR TO BEING DISCHARGED, AND AGAIN APPROXIMATELY 1 WEEK POST OP. IT WAS REPORTED THAT THE PATIENT HAS A PRE-EXISTING NEUROLOGICAL CONDITION THAT MADE THEM A FALLS RISK. THE SURGEON WHO PERFORMED THE PRIMARY AND REVISION SURGERIES CONFIRMED THAT HE BELIEVED THESE DISLOCATIONS TO BE THE RESULT OF THE PATIENT'S NEUROLOGICAL CONDITION. 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
    1193550 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 KRO_EM_19257

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other