BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES

    MDR report key: 8105806 · Received November 27, 2018

    Report

    Report Number
    3005180920-2018-00950
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 30, 2018
    Report Date
    November 27, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810855
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 NOVEMBER 2018: LOT 161068: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2016. EXPIRATION DATE: 2021-08-17. 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. ADDITIONAL COMPONENTS REVISED: STEM: MASTERLOC 01.39.205 CEMENTLESS TI COATED LAT STEM SIZE 5 (K151531), LOT 162207: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 JUNE 2016. EXPIRATION DATE: 2021-06-14. 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. SCREWS: MPACT 01.32.6540 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40 (K103721), LOT 168800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 FEBRUARY 2017. EXPIRATION DATE: 2022-02-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT 1 SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721), LOT 168473: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 MARCH 2017. EXPIRATION DATE: 2022-02-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115), LOT 164224: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 OCTOBER 2016. EXPIRATION DATE: 2021-10-02. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 2 SIMILAR REPORTED EVENTS. MPACT 01.31.55TP SHELL SCREW PLUG (K103721), LOT 160676: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 FEBRUARY 2016 . EXPIRATION DATE: 2021-01-25. 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

    REVISION SURGERY PERFORMED AFTER ABOUT 1 YEAR AND 3 MONTHS DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN AT THIS TIME. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945720 CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES CEMENTLESS HIP SHELL LPH MEDACTA INTERNATIONAL SA 161068 07630030810855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention