BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 56 TWO-HOLES

    MDR report key: 10593620 · Received September 28, 2020

    Report

    Report Number
    3005180920-2020-00667
    Event Type
    Injury
    Date Received
    September 28, 2020
    Date of Event
    September 3, 2019
    Report Date
    September 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030802041
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 178262: 120 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2018. EXPIRATION DATE: 2023-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 110 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANOTHER 1 SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT LINER: IMPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F LOT. 166667 (K103721) BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 166667: 77 ITEMS MANUFACTURED AND RELEASED ON 13-DEC-10§6. EXPIRATION DATE: 2011-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 74 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 LOT. 176376 (K112115) BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 176376: 220 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2018. EXPIRATION DATE: 2022-12-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. STEM: QUADRA-H 01.12.034 CEMENTLESS, HA COATED LAT STEM # 4 LOT. 174068 (K082792) BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 174068: 39 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: 2022-11-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 37 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    1 YEAR AND 2 MONTHS AFTER PRIMARY, REVISION SURGERY PERFORMED DUE TO INFECTION. RIGHT SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058127 CUP: MPACT ACETABULAR SHELL 56 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.12.023 178262 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention