BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 6979324 · Received October 26, 2017

    Report

    Report Number
    3005180920-2017-00613
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 26, 2017
    Report Date
    October 26, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 OCTOBER 2017. LOT 168442: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 MARCH 2017. EXPIRATION DATE: 2022-02-20. 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. MASTERLOC CEMENTLESS TI COATED STEM SIZE 9 LAT, CODE 01.39.209, LOT. 156738 (K151531) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MARCH 2016. EXPIRATION DATE: 2021-03-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT FLAT PE HC LINER Ø36/E, CODE 01.32.3644HCT, LOT. 168470 (K103721) LOT 168470: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MARCH 2017. EXPIRATION DATE: 2022-02-13. NO ANOMALIES FOUND RELATED TO THE REPORTED ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE LOT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0, CODE 01.29.209, LOT. 170697 (K112115) LOT 170697: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2017. EXPIRATION DATE: 2022-05-11. 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. MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25, CODE 01.32.6525, LOT. 170647 (K103721) LOT 170647: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MARCH 2017. EXPIRATION DATE: 2022-03-05. 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 DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758605 MPACT ACETABULAR SHELL Ø54 TWO-HOLES CEMENTLESS ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 168442 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention