BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9634717 · Received January 27, 2020

    Report

    Report Number
    3012916784-2020-00049
    Event Type
    Injury
    Date Received
    January 27, 2020
    Date of Event
    December 3, 2019
    Report Date
    February 13, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT RECEIVED PRIMARY THA PROCEDURE (B)(6) 2017, AND IMMEDIATELY DISLOCATED IN THE POST-OP ROOM. THE PATIENT THEN REPORTED INSTABILITY IN THE HIP FOR THE NEXT 2 YEARS AND WAS REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) AND FHA REPORT IN THE PRIMARY SURGERY. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER OF THIS ISSUE TO COMPARE THE PLANNED AND ACHIEVED POSITIONING OF THE POSITIONING. A ROOT CAUSE INVESTIGATION HAS NOW BEEN CONDUCTED INTO THIS EVENT. THE POST-OPERATIVE IMAGING PROVIDED BY THE REPORTER WAS NOT IN A DICOM FORMAT AND THEREFORE WAS UNABLE TO BE ACCURATELY ANALYSED. ALL PRODUCTS PROVIDED TO THE PRIMARY SURGERY WERE CONFIRMED TO HAVE BEEN MANUFACTURED ACCORDING TO SPECIFICATION. IT WAS DETERMINED FROM THE PRE-OPERATIVE ANALYSIS THAT THIS PATIENT HAD TWO UNAVOIDABLE RISK FACTORS FOR DISLOCATION. FIRSTLY, THE PATIENT'S PELVIC ROTATION FROM SUPINE TO STANDING IS LARGE (FROM 9 DEGREES TO -4.8 DEGREES). SECONDLY, THE PATIENT'S L5 AND L4 WERE FUSED, RESTRICTING SPINAL MOBILITY. THESE TWO FACTORS HAVE BEEN IDENTIFIED IN LITERATURE AS FACTORS WHICH INCREASE DISLOCATION RISK. THE POSTION OF THE IMPLANTS (I.E. ACHIEVED POSITIONING COMPARED TO PLANNED) WAS UNABLE TO BE ACCURATELY DETERMINED FROM THE POST-OPERATIVE IMAGING PROVIDED. IT WAS DETERMINED THAT THE LIKELY CAUSE OF THIS EVENT WOULD BE FACTORS OUTSIDE OF THE CONTROL OF THE OPS ANALYSIS PROVIDED TO THE SURGEON FOR THE PRIMARY SURGERY. 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 THA PROCEDURE (B)(6) 2017, AND IMMEDIATELY DISLOCATED IN THE POST-OP ROOM. THE PATIENT THEN REPORTED INSTABILITY IN THE HIP FOR THE NEXT 2 YEARS AND WAS REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) AND FHA REPORT IN THE PRIMARY SURGERY. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER OF THIS ISSUE TO COMPARE THE PLANNED AND ACHIEVED POSITIONING OF THE POSITIONING. A ROOT CAUSE INVESTIGATION HAS NOW BEEN CONDUCTED INTO THIS EVENT. THE POST-OPERATIVE IMAGING PROVIDED BY THE REPORTER WAS NOT IN A DICOM FORMAT AND THEREFORE WAS UNABLE TO BE ACCURATELY ANALYSED. ALL PRODUCTS PROVIDED TO THE PRIMARY SURGERY WERE CONFIRMED TO HAVE BEEN MANUFACTURED ACCORDING TO SPECIFICATION. IT WAS DETERMINED FROM THE PRE-OPERATIVE ANALYSIS THAT THIS PATIENT HAD TWO UNAVOIDABLE RISK FACTORS FOR DISLOCATION. FIRSTLY, THE PATIENT'S PELVIC ROTATION FROM SUPINE TO STANDING IS LARGE (FROM 9 DEGREES TO -4.8 DEGREES). SECONDLY, THE PATIENT'S L5 AND L4 WERE FUSED, RESTRICTING SPINAL MOBILITY. THESE TWO FACTORS HAVE BEEN IDENTIFIED IN LITERATURE AS FACTORS WHICH INCREASE DISLOCATION RISK. THE POSITON OF THE IMPLANTS (I.E. ACHIEVED POSITIONING COMPARED TO PLANNED) WAS UNABLE TO BE ACCURATELY DETERMINED FROM THE POST-OPERATIVE IMAGING PROVIDED. IT WAS DETERMINED THAT THE LIKELY CAUSE OF THIS EVENT WOULD BE FACTORS OUTSIDE OF THE CONTROL OF THE OPS ANALYSIS PROVIDED TO THE SURGEON FOR THE PRIMARY SURGERY.

    Additional Manufacturer Narrative · 1

    PATIENT RECEIVED PRIMARY THA PROCEDURE (B)(6) 2017, AND IMMEDIATELY DISLOCATED IN THE POST-OP ROOM. THE PATIENT THEN REPORTED INSTABILITY IN THE HIP FOR THE NEXT 2 YEARS AND WAS REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) AND FHA REPORT IN THE PRIMARY SURGERY. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER OF THIS ISSUE TO COMPARE THE PLANNED AND ACHIEVED POSITIONING OF THE POSITIONING. 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 THA PROCEDURE (B)(6) 2017, AND IMMEDIATELY DISLOCATED IN THE POST-OP ROOM. THE PATIENT THEN REPORTED INSTABILITY IN THE HIP FOR THE NEXT 2 YEARS AND WAS REVISED ON (B)(6) 2019. PATIENT RECEIVED THE USE OF THE PATIENT SPECIFIC ACETABULAR GUIDE (K152893) AND FHA REPORT IN THE PRIMARY SURGERY. POST-OPERATIVE IMAGING HAS BEEN REQUESTED FROM THE REPORTER OF THIS ISSUE TO COMPARE THE PLANNED AND ACHIEVED POSITIONING OF THE POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97077 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD 1248-1500 ANG_SR_7494H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention