BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9448175 · Received December 10, 2019

    Report

    Report Number
    3012916784-2019-00029
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 25, 2019
    Report Date
    January 16, 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 (B)(6) 2019, WAS RECURRENTLY DISLOCATING FROM (B)(6) 2019, AND WAS REVISED (B)(6) 2019 FOR DISLOCATION. 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. A ROOT CAUSE INVESTIGATION HAS BEEN CONDUCTED INTO THIS EVENT. THE PRE-OPERATIVE PLANNING WAS REVIEWED AND IT WAS DETERMINED THAT ALL OPERATIONS WERE PERFORMED ACCORDING TO WORK INSTRUCTIONS AND ALL PRODUCTS PROVIDED TO THE PRIMARY SURGERY WERE CONFIRMED TO BE MANUFACTURED TO SPECIFICATION. NO ROOT CAUSE FOR THIS DISLOCATION COULD BE DETERMINED. 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 (B)(6) 2019, WAS RECURRENTLY DISLOCATING FROM NOVEMBER (B)(6) 2019, AND WAS REVISED (B)(6) 2019 FOR DISLOCATION. 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. A ROOT CAUSE INVESTIGATION HAS BEEN CONDUCTED INTO THIS EVENT. THE PRE-OPERATIVE PLANNING WAS REVIEWED AND IT WAS DETERMINED THAT ALL OPERATIONS WERE PERFORMED ACCORDING TO WORK INSTRUCTIONS AND ALL PRODUCTS PROVIDED TO THE PRIMARY SURGERY WERE CONFIRMED TO BE MANUFACTURED TO SPECIFICATION. NO ROOT CAUSE FOR THIS DISLOCATION COULD BE DETERMINED. 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 JULY 22, 2019, WAS RECURRENTLY DISLOCATING FROM (B)(6) 2019, AND WAS REVISED (B)(6) 2019 FOR DISLOCATION. 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, WAS RECURRENTLY DISLOCATING FROM (B)(6) 2019, AND WAS REVISED (B)(6) 2019 FOR DISLOCATION. 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
    1242979 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 WAR_AS_17203

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention