BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9448481 · Received December 10, 2019

    Report

    Report Number
    3012916784-2019-00030
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    December 2, 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 HIP SURGERY ON (B)(6) 2019 AND WAS REPORTED TO DISLOCATE WHEN THEY LIFT THEIR KNEE ON (B)(6) 2019. 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. A ROOT CAUSE INVESTIGATION HAS BEEN CONDUCTED INTO THIS EVENT. NO POST-OPERATIVE IMAGING WAS AVAILABLE FOR REVIEW AND SO IT WAS NOT POSSIBLE TO COMPARE THE PRE-OPERATIVE PLAN AND ACHIEVED POSITIONING OF IMPLANTS DURING THE PRIMARY SURGERY. THE PRE-OPERATIVE PLANNING FOR THIS PATIENT SHOWED THAT THIS PATIENT WAS AT RISK OF ANTERIOR PROSTHETIC IMPINGEMENT IN ALL TESTED ACETABULAR ORIENTATIONS, LEADING TO AN INCREASED RISK OF DISLOCATION. CLINICAL ASSESSMENT SUGGESTED THAT A DUAL MOBILITY LINER MAY HAVE BEEN BENEFICIAL TO HAVE BEEN USED DURING THE PRIMARY SURGERY. ALL OPERATIONS WERE CONFIRMED TO HAVE BEEN COMPLETED ACCORDING TO WORK INSTRUCTIONS AND ALL PRODUCTS PROVIDED TO THE PRIMARY SURGERY WERE MANUFACTURED ACCORDING TO SPECIFICATION. THE ROOT CAUSE OF THIS ISSUE WAS DETERMINED TO BE RELATED TO PRE-EXISTING PATIENT SPECIFIC ISSUES, UNRELATED TO THE USE OF OPS TECHNOLOGY IN 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 · 0

    PATIENT RECEIVED PRIMARY HIP SURGERY ON (B)(6) 2019 AND WAS REPORTED TO DISLOCATE WHEN THEY LIFT THEIR KNEE ON (B)(6) 2019. 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. A ROOT CAUSE INVESTIGATION HAS BEEN CONDUCTED INTO THIS EVENT. NO POST-OPERATIVE IMAGING WAS AVAILABLE FOR REVIEW AND SO IT WAS NOT POSSIBLE TO COMPARE THE PRE-OPERATIVE PLAN AND ACHIEVED POSITIONING OF IMPLANTS DURING THE PRIMARY SURGERY. THE PRE-OPERATIVE PLANNING FOR THIS PATIENT SHOWED THAT THIS PATIENT WAS AT RISK OF ANTERIOR PROSTHETIC IMPINGEMENT IN ALL TESTED ACETABULAR ORIENTATIONS, LEADING TO AN INCREASED RISK OF DISLOCATION. CLINICAL ASSESSMENT SUGGESTED THAT A DUAL MOBILITY LINER MAY HAVE BEEN BENEFICIAL TO HAVE BEEN USED DURING THE PRIMARY SURGERY. ALL OPERATIONS WERE CONFIRMED TO HAVE BEEN COMPLETED ACCORDING TO WORK INSTRUCTIONS AND ALL PRODUCTS PROVIDED TO THE PRIMARY SURGERY WERE MANUFACTURED ACCORDING TO SPECIFICATION. THE ROOT CAUSE OF THIS ISSUE WAS DETERMINED TO BE RELATED TO PRE-EXISTING PATIENT SPECIFIC ISSUES, UNRELATED TO THE USE OF OPS TECHNOLOGY IN 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.

    Additional Manufacturer Narrative · 1

    PATIENT RECEIVED PRIMARY HIP SURGERY ON (B)(6) 2019 AND WAS REPORTED TO DISLOCATE WHEN THEY LIFT THEIR KNEE ON (B)(6) 2019. 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 HIP SURGERY ON (B)(6) 2019 AND WAS REPORTED TO DISLOCATE WHEN THEY LIFT THEIR KNEE ON (B)(6) 2019. 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
    1242960 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 AIT_UD_14717

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention