BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFTICUP CC TRIO ACETABULAR SHELL Ø 58

    MDR report key: 7070539 · Received November 30, 2017

    Report

    Report Number
    3005180920-2017-00712
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 30, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807800
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 17 NOV 2017 THE MEDICAL AFFAIRS MADE THE FOLLOWING ANALYSIS: PARTIAL HIP REVISION SURGERY (CUP, HEAD AND LINER) DUE TO DISLOCATION OCCURRED DURING THE FIRST POSTOPERATIVE MONTH. ACCORDING TO THE REPORT, THE REASON OF THIS EVENT IS PROBABLY LINKED TO A SUBOPTIMAL COMPONENT POSITIONING DURING PRIMARY IMPLANTATION. DISLOCATION MAY ALSO BE CAUSED BY INSUFFICIENT SOFT TISSUE TENSION BUT IT CAN HARDLY BE CAUSED BY STANDARD DEVICES BATCH REVIEW PERFORMED ON 30 NOVEMBER 2017: LOT 170091: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MAY 2017. EXPIRATION DATE: 2022-05-08. 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. VERSAFITCUP CC FLAT PE HC Ø LINER 36 / F REF. 01.26.3648HCT LOT. 172578 (K103352): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2017. EXPIRATION DATE: 2022-07-06. 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. COCR BALL HEAD 12/14 Ø 36 SIZE M REF. 01.25.031 LOT. 166598 (K080885): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JANUARY 2017. EXPIRATION DATE: 2022-01-08. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF DISCOMFORT. THE SURGEON DETERMINED THE PATIENT HAD DISLOCATED HIS HIP, THE PATIENT WAS DISLOCATING POSTERIORLY. THE CUP WAS NOT ANTEVERTED ENOUGH. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849305 VERSAFTICUP CC TRIO ACETABULAR SHELL Ø 58 CEMENTLESS ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 170091 07630030807800

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention