BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL Ø 52

    MDR report key: 6047242 · Received October 21, 2016

    Report

    Report Number
    3005180920-2016-00538
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 21, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON USED THE AMIS APPROACH FOR THE PRIMARY CASE. BATCH REVIEWS PERFORMED ON 17 OCTOBER 2016. LOT 090243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 APRIL 2009. EXPIRATION DATE: 2014-03-31. 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. QUADRA-H CEMENTLESS, HA COATED STEM SIZE 5 LAT, CODE 01.12.035, LOT. 091202 (K082792) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 AUGUST 2009. EXPIRATION DATE: 2014-05-31. 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. ON (B)(6) 2016 THE (B)(6) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: MOBILIZED DM CUP IN CEMENTLESS THA 7 YEARS AFTER PRIMARY. FEW IMAGES ARE AVAILABLE, NO POST-PRIMARY X-RAYS. FROM THE FLUOROSCOPIC SHOT, THE CUP APPEARS TO HAVE PROBABLY MIGRATED MEDIALLY. THE PICTURES OF THE EXPLANT SHOW LITTLE SIGNS OF BONE ONGROWTH ON THE CUP EXTERNAL SURFACE. WE CANNOT DETERMINE IF THIS POOR FIXATION OF THE CUP ONSET FROM THE VERY BEGINNING OR IF IT IS A SECONDARY EVOLUTION BECAUSE THERE IS NO X-RAY HISTORY AVAILABLE. NO COMMENTS ON POSSIBLE INFECTIONS WERE MADE, THEREFORE WE MUST ASSUME THAT THIS IS AN ASEPTIC LOOSENING CASE. THE STEM APPEARS WELL POSITIONED AND IT IS LIKELY THAT THE MODEST SIGNS OF OSTEOLYSIS WILL RECEDE DURING POSTOPERATIVE PERIOD. ON (B)(6) 2016 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION AND COMMENTED AS FOLLOWS: MOBILIZED DM CUP IN CEMENTLESS THA 7 YEARS AFTER PRIMARY. FEW IMAGES ARE AVAILABLE, NO POST-PRIMARY X-RAYS. FROM THE FLUOROSCOPIC SHOT, THE CUP APPEARS TO HAVE PROBABLY MIGRATED MEDIALLY. THE PICTURES OF THE EXPLANT SHOW LITTLE SIGNS OF BONE ONGROWTH ON THE CUP EXTERNAL SURFACE. WE CANNOT DETERMINE IF THIS POOR FIXATION OF THE CUP ONSET FROM THE VERY BEGINNING OR IF IT IS A SECONDARY EVOLUTION BECAUSE THERE IS NO X-RAY HISTORY AVAILABLE. NO COMMENTS ON POSSIBLE INFECTIONS WERE MADE, THEREFORE WE MUST ASSUME THAT THIS IS AN ASEPTIC LOOSENING CASE. THE STEM APPEARS WELL POSITIONED AND IT IS LIKELY THAT THE MODEST SIGNS OF OSTEOLYSIS WILL RECEDE DURING POSTOPERATIVE PERIOD.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON NOTICED OSTEOLYSIS AROUND THE PROXIMAL PART OF THE STEM AND A SMALL RADIOLUCENCY AROUND THE CUP. THE CUP WAS LOOSE AS WELL. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699655 VERSAFITCUP ACETABULAR SHELL Ø 52 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 090243

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention