BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9455855 · Received December 12, 2019

    Report

    Report Number
    3012916784-2019-00036
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 12, 2019
    Report Date
    January 10, 2020
    Manufacturer
    OPTIMIZED ORTHO PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K152893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE T-HANDLE (K152893) DID NOT FIT INTO THE PELVIC SCREW (K152893). IN THIS CASE, THE SURGERY PROCEEDED WITH THE USE OF THESE NON-COMPATIBLE INSTRUMENTS AND USED BONE CEMENT TO ATTACH THE TWO INSTRUMENTS TOGETHER. ERRORS OF OPERATIVE TECHNIQUE AND IMPROPER POSITIONING OR INADEQUATE ASSEMBLY OF OPTIMIZED POSITIONING SYSTEM¿ COMPONENTS MAY RESULT IN LIMB LENGTH DISCREPANCIES AND/OR FAILURE TO IMPLANT THE ACETABULAR AND AND FEMORAL COMPONENTS IN THE DESIRED ORIENTATION AND POSITION. DEVICES HAVE BEEN REQUESTED FOR RETURN FOR FURTHER INVESTIGATION. THE PATIENT INVOLVED IN THIS ISSUE WAS NOT REPORTED TO HAVE EXPERIENCED ANY ADVERSE EVENT AS A RESULT OF THIS ISSUE. THREE WRITTEN GOOD FAITH ATTEMPTS WERE MADE TO RETRIEVE THE DEVICES THEMSELVES AS WELL AS THE PART AND LOT NUMBERS OF THE DEVICES INVOLVED, IN ORDER TO RETRIEVE THE MANUFACTURING AND INSPECTIONS RECORDS AND CONDUCT A FULL ROOT CAUSE ANALYSIS. THE REPORTER OF THE ISSUE DID NOT REPLY TO THIS WRITTEN COMMUNICATION, NOR DID THEY REPLY TO THE PHONE CALLS MADE REGARDING THIS ISSUE. NO DEVICES MATCHING THIS DESCRIPTION WERE RETURNED TO OPTIMIZED ORTHO AND SO IT WAS DETERMINED THAT THE DEVICES WERE LIKELY DISCARDED. THROUGH THE ROOT CAUSE INVESTIGATION THAT WAS ABLE TO BE CONDUCTED, IT WAS FOUND THAT THERE WERE NO OTHER REPORTS OF THIS ISSUE, BOTH IN THE FIELD AND PRIOR TO RELEASE OF PRODUCTS. AS A RESULT OF THIS, NO ROOT CAUSE OF THIS ISSUE WAS ABLE TO BE DETERMINED. THIS ISSUE WILL CONTINUE TO BE MONITORED FOR RECURRENCE. 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

    THE T-HANDLE (K152893) DID NOT FIT INTO THE PELVIC SCREW (K152893). IN THIS CASE, THE SURGERY PROCEEDED WITH THE USE OF THESE NON-COMPATIBLE INSTRUMENTS AND USED BONE CEMENT TO ATTACH THE TWO INSTRUMENTS TOGETHER. ERRORS OF OPERATIVE TECHNIQUE AND IMPROPER POSITIONING OR INADEQUATE ASSEMBLY OF OPTIMIZED POSITIONING SYSTEM¿ COMPONENTS MAY RESULT IN LIMB LENGTH DISCREPANCIES AND/OR FAILURE TO IMPLANT THE ACETABULAR AND FEMORAL COMPONENTS IN THE DESIRED ORIENTATION AND POSITION. DEVICES HAVE BEEN REQUESTED FOR RETURN FOR FURTHER INVESTIGATION. THE PATIENT INVOLVED IN THIS ISSUE WAS NOT REPORTED TO HAVE EXPERIENCED ANY ADVERSE EVENT AS A RESULT OF THIS ISSUE. THREE WRITTEN GOOD FAITH ATTEMPTS WERE MADE TO RETRIEVE THE DEVICES THEMSELVES AS WELL AS THE PART AND LOT NUMBERS OF THE DEVICES INVOLVED, IN ORDER TO RETRIEVE THE MANUFACTURING AND INSPECTIONS RECORDS AND CONDUCT A FULL ROOT CAUSE ANALYSIS. THE REPORTER OF THE ISSUE DID NOT REPLY TO THIS WRITTEN COMMUNICATION, NOR DID THEY REPLY TO THE PHONE CALLS MADE REGARDING THIS ISSUE. NO DEVICES MATCHING THIS DESCRIPTION WERE RETURNED TO OPTIMIZED ORTHO AND SO IT WAS DETERMINED THAT THE DEVICES WERE LIKELY DISCARDED. THROUGH THE ROOT CAUSE INVESTIGATION THAT WAS ABLE TO BE CONDUCTED, IT WAS FOUND THAT THERE WERE NO OTHER REPORTS OF THIS ISSUE, BOTH IN THE FIELD AND PRIOR TO RELEASE OF PRODUCTS. AS A RESULT OF THIS, NO ROOT CAUSE OF THIS ISSUE WAS ABLE TO BE DETERMINED. THIS ISSUE WILL CONTINUE TO BE MONITORED FOR RECURRENCE. 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

    THE T-HANDLE (K152893) DID NOT FIT INTO THE PELVIC SCREW (K152893). IN THIS CASE, THE SURGERY PROCEEDED WITH THE USE OF THESE NON-COMPATIBLE INSTRUMENTS AND USED BONE CEMENT TO ATTACH THE TWO INSTRUMENTS TOGETHER. ERRORS OF OPERATIVE TECHNIQUE AND IMPROPER POSITIONING OR INADEQUATE ASSEMBLY OF OPTIMIZED POSITIONING SYSTEM¿ COMPONENTS MAY RESULT IN LIMB LENGTH DISCREPANCIES AND/OR FAILURE TO IMPLANT THE ACETABULAR AND FEMORAL COMPONENTS IN THE DESIRED ORIENTATION AND POSITION. DEVICES HAVE BEEN REQUESTED FOR RETURN FOR FURTHER INVESTIGATION. 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 · 1

    THE T-HANDLE (K152893) DID NOT FIT INTO THE PELVIC SCREW (K152893). IN THIS CASE, THE SURGERY PROCEEDED WITH THE USE OF THESE NON-COMPATIBLE INSTRUMENTS AND USED BONE CEMENT TO ATTACH THE TWO INSTRUMENTS TOGETHER. ERRORS OF OPERATIVE TECHNIQUE AND IMPROPER POSITIONING OR INADEQUATE ASSEMBLY OF OPTIMIZED POSITIONING SYSTEM¿ COMPONENTS MAY RESULT IN LIMB LENGTH DISCREPANCIES AND/OR FAILURE TO IMPLANT THE ACETABULAR AND FEMORAL COMPONENTS IN THE DESIRED ORIENTATION AND POSITION. DEVICES HAVE BEEN REQUESTED FOR RETURN FOR FURTHER INVESTIGATION. 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
    1258070 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO OPTIMIZED ORTHO PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR