BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 54

    MDR report key: 8699969 · Received June 14, 2019

    Report

    Report Number
    3005180920-2019-00462
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 14, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808128
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 JUNE 2019: LOT 092647: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2010. EXPIRATION DATE: 2014-12-31. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 9 YEARS AFTER PRIMARY CEMENTLESS THA WITH DOUBLE MOBILITY CUP THE PATIENT COMPLAINS OF PAIN. THE IMAGES PROVIDED SHOW A MALPOSITIONED AND OVERSIZED CUP, BUT WE CANNOT DETERMINE IF THIS POSITION IS THE RESULT OF MIGRATION OR IT'S THE ORIGINAL IMPLANT POSITION BECAUSE THE WE CANNOT READ DATES ON RADIOGRAPHS. IT IS CONCEIVABLE, BASED ON THE SCARCE INFORMATION SUPPLIED, THAT THE ORIGIN OF PAIN IS THE LATERALLY PROTRUDING CUP. THE EXCHANGE OF HEAD AND LINER IS ROUTINE IN THIS CASE. ACCORDING TO REPORT, NONE OF THE IMPLANTED DEVICES HAS MALFUNCTIONED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 8 YEARS AND 7 MONTHS AFTER PRIMARY DUE TO HIP PAIN AND TIGHTNESS. DURING THE REVISION SURGERY THE STEM AND THE CUP WERE WELL FIXED, THE LINER AND THE BALL HEAD HAVE BEEN REVISED AS STANDARD PROCEDURE. THE IMAGES PROVIDED SHOW A MALPOSITIONED AND OVERSIZED CUP, AND IT IS CONCEIVABLE, BASED ON THE SCARCE INFORMATION SUPPLIED, THAT THE ORIGIN OF PAIN IS THE LATERALLY PROTRUDING CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494220 CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 54 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 092647 07630030808128

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention