BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9455593 · Received December 11, 2019

    Report

    Report Number
    3012916784-2019-00033
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    November 30, 2019
    Report Date
    January 15, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT RECEIVED PRIMARY SURGERY ON (B)(6) 2019. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FALL FROM THEIR TRUCK WHICH RESULTED IN A PERIPROSTHETIC FRACTURE. THE PATIENT WAS THEN REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND DHA REPORT IN THE PRIMARY SURGERY. A ROOT CAUSE INVESTIGATION WAS CONDUCTED INTO THIS EVENT. IT WAS FOUND THAT ALL PRODUCTS PROVIDED TO THE PRIMARY SURGERY WERE MANUFACTURED ACCORDING TO SPECIFICATION. THE SURGEON ELECTED TO USE A SMALLER STEM SIZE COMPARED TO THE PLANNED SIZE IN THE PRIMARY SURGERY. THIS CHANGE MAY HAVE BEEN DUE TO THE RELATIVELY YOUNG AGE OF THE PATIENT, HOWEVER MAY HAVE ADVERSELY AFFECTED THE POSITIONING OF THE STEM. POST-OPERATIVE IMAGING WAS REQUESTED TO ANALYSE THE POSITIONING OF THE IMPLANTS, HOWEVER THIS WAS NOT ABLE TO BE PROVIDED BY THE SURGEON REPRESENTATIVE. IT WAS DETERMINED THAT THE FRACTURE WAS PREDOMINANTLY CAUSED BY A JUMP FROM A YOUNG ACTIVE PATIENT BUT MAY HAVE BEEN AFFECTED BY INTRA-OPERATIVE DOWNSIZING OF THE FEMORAL STEM COMPARED TO THE PLANNED SIZE. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. 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 RECEIVED PRIMARY SURGERY ON (B)(6) 2019. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FALL FROM THEIR TRUCK WHICH RESULTED IN A PERIPROSTHETIC FRACTURE. THE PATIENT WAS THEN REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND DHA REPORT IN THE PRIMARY SURGERY. A ROOT CAUSE INVESTIGATION WAS CONDUCTED INTO THIS EVENT. IT WAS FOUND THAT ALL PRODUCTS PROVIDED TO THE PRIMARY SURGERY WERE MANUFACTURED ACCORDING TO SPECIFICATION. THE SURGEON ELECTED TO USE A SMALLER STEM SIZE COMPARED TO THE PLANNED SIZE IN THE PRIMARY SURGERY. THIS CHANGE MAY HAVE BEEN DUE TO THE RELATIVELY YOUNG AGE OF THE PATIENT, HOWEVER MAY HAVE ADVERSELY AFFECTED THE POSITIONING OF THE STEM. POST-OPERATIVE IMAGING WAS REQUESTED TO ANALYSE THE POSITIONING OF THE IMPLANTS, HOWEVER THIS WAS NOT ABLE TO BE PROVIDED BY THE SURGEON REPRESENTATIVE. IT WAS DETERMINED THAT THE FRACTURE WAS PREDOMINANTLY CAUSED BY A JUMP FROM A YOUNG ACTIVE PATIENT BUT MAY HAVE BEEN AFFECTED BY INTRA-OPERATIVE DOWNSIZING OF THE FEMORAL STEM COMPARED TO THE PLANNED SIZE. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. 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 PRIMARY SURGERY (B)(6) 2019. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FALL FROM THEIR TRUCK WHICH RESULTED IN A PERIPROSTHETIC FRACTURE. THE PATIENT WAS THEN REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND DHA REPORT IN THE PRIMARY SURGERY. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. 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 PRIMARY SURGERY (B)(6) 2019. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FALL FROM THEIR TRUCK WHICH RESULTED IN A PERIPROSTHETIC FRACTURE. THE PATIENT WAS THEN REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND DHA REPORT IN THE PRIMARY SURGERY. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. 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
    1249663 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD KAT_UD_18985

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention