BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 8069025 · Received November 14, 2018

    Report

    Report Number
    3005180920-2018-00901
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    February 26, 2018
    Report Date
    October 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    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 13 NOVEMBER 2018 LOT 174269:7 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 NOVEMBER 2017. EXPIRATION DATE: 2022-11-13. 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 FLAT PE HC LINER Ø 36/E REFERENCE 01.32.3644HCT. LOT 174523: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2017. EXPIRATION DATE: 2022-11-27. 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 40 REFERENCE 01.32.6540. LOT 172444: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 AUGUST 2017. EXPIRATION DATE: 2022-08-17. 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. AMISTEM H HA COATED STD STEM SIZE 2 REFERENCE 01.18.132. LOT 170810: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JULY 2017. EXPIRATION DATE: 2022-07-04. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 REFERENCE 01.29.209. LOT 174720: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 NOVEMBER 2017. EXPIRATION DATE: 2022-11-06. 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.

    Description of Event or Problem · 1

    ABOUT 8 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION. ALL HARDWARE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910618 MPACT ACETABULAR SHELL Ø54 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 174269 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention