BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR CEMENTLESS SHELL Ø 58

    MDR report key: 5289463 · Received December 11, 2015

    Report

    Report Number
    3005180920-2015-00326
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 13, 2015
    Report Date
    February 12, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE SURGEON AFTHER THE REVISION ((B)(6) 3015): THE PATIENT HAS PERSISTENT GROIN PAIN, THE REVISION WAS SUCCESSFUL. THE SURGEON THINKS THAT THE ANTEVERSION OF THE CUP WAS TOO LARGE CAUSING THE PAIN. THE CUP HAS BEEN REMOVED BUT THE SURGEON HAS NO COMMENTS ON THE CUP. THE CUP WAS STRONGLY INGRAINED WITH A LOT OF SCAR TISSUE. THE SURGEON HAS PUT ANOTHER CUP WITH LESS ANTIVERSION 25° ( THE VERSAFIT TRIO HAS 35°) THE SURGEON DOES NOT NOW THE ROOT CAUSE OF THE GROIN PAIN. ON (B)(6) 2015 IT WAS CONFIRMED THAT X-RAY AND EXPLANTS WILL BE AVAILABLE. BATCH REVIEW PERFORMED ON 07 DECEMBER 2015: LOT 142407: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 JULY 2014. EXPIRATION DATE: 2019-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT RECEIVED BACK YET.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2015 THE R&D PROJECT MANAGER ANALYSED THE RETURNED IMPLANTS OBSERVING THE ACETABULAR SHELL, SOME SIGNS AND SCRATCHES CAN BE NOTED ON THE BORDER, PROBABLY DUE TO THE REMOVAL PHASE. ON THE EXTERNAL SURFACE OF THE CUP, BONE CAN BE SEEN ON ALL THE SPHERICAL ZONE AND ON SOME PORTION OF THE EQUATORIAL MACROSTRUCTURES. THE LINER IS ASSEMBLED TO THE SHELL, SOME SCRATCHES ON BOTH THE INTERNAL SPHERICAL SURFACE AND THE BORDER CAN BE SEEN ON IT, PROBABLY CAUSED BY THE REVISION SURGERY. OBSERVING THE CERAMIC HEAD, SOME SIGNS AND SCRATCHES CAN BE NOTED ON BOTH THE INTERNAL CONICAL SURFACE AND THE EXTERNAL SURFACE, PROBABLY DUE TO THE REMOVAL PHASE. ANYWAY, NO ANOMALIES WERE FOUND RELATED TO THE LOTS INVOLVED IN THE CLAIM. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    PRE- AND POST- REVISION X-RAYS RECEIVED ON 15 JANUARY 2016. ON THE SAME DATE, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: ACCORDING TO REPORT, THIS PATIENT HAD PAIN, AND A POSSIBLE CAUSE, ACCORDING TO THE SURGEON, COULD HAVE BEEN AN EXCESSIVE ANTEVERSION OF THE ORIGINAL ACETABULAR CUP, PERHAPS GIVEN IN ORDER TO MAXIMIZE RANGE OF MOTION IN FLEXION. THE QUALITY OF THE PRE-REVISION X-RAY DOES NOT ALLOW TO EVALUATE CUP ANTEVERSION WITH REASONABLE PRECISION, AND THE WHOLE PELVIS IS NOT VISIBLE, SO THIS CONDITION CANNOT BE ASSESSED. ACCORDING TO REPORT AND PICTURE, THE CUP WAS WELL FIXED IN THE BONE. PAIN MIGHT HAVE BEEN CAUSED BY MUSCLES SCRATCHING ON THE CUP BECAUSE OF THE PARTICULAR ANATOMY OF THE PATIENT, BUT THIS CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. ON 11 FEBRUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE PREVIOUS REPORTS AND HERE ABOVE. ON 12 FEBRUARY 2016, THE FINAL REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT HAD PAIN , THE SURGEON WILL REMOVE THE CUP BECAUSE IT IS PROBABLY MISPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819888 VERSAFITCUP CC TRIO ACETABULAR CEMENTLESS SHELL Ø 58 ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 142407

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention