BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø50 TWO-HOLES

    MDR report key: 7514386 · Received May 15, 2018

    Report

    Report Number
    3005180920-2018-00327
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    April 16, 2018
    Report Date
    September 5, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE RECEIVED ON 07 AUGUST 2018: ON (B)(6) 2018 THE SURGEON REMOVED THE SPACER AND IMPLANTED ANOTHER SPACER AS THE INFECTION HAS NOT SUBSIDED. THE INFECTION HAS BEEN CONFIRMED AS STAPH EPI. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 MAY2018. LOT 166604: 78 ITEMS MANUFACTURED AND RELEASED ON 20 JANUARY 2017. EXPIRATION DATE: 2022-01-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 74 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHERS DEVICES INVOLVED: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 2 REFERENCE (B)(4). LOT 166466: 100 ITEMS MANUFACTURED AND RELEASED ON 11 JANUARY 2017. EXPIRATION DATE: 2022-01-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 93 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 (B)(4). LOT 168800: 130 ITEMS MANUFACTURED AND RELEASED ON 15 FEBRUARY 2017. EXPIRATION DATE: 2022-02-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 78 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 REFERENCE (B)(4). LOT 168792: 169 ITEMS MANUFACTURED AND RELEASED ON 06 FEBRUARY 2017. EXPIRATION DATE: 2022-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 144 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 REFERENCE (B)(4). LOT 162726: 80 ITEMS MANUFACTURED AND RELEASED ON 27 JULY 2016. EXPIRATION DATE: 2021-07-19 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 59 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT SHELL SCREW PLUG REFERENCE (B)(4). LOT 168461: 120 ITEMS MANUFACTURED AND RELEASED ON 16 DECEMBER 2016. EXPIRATION DATE: 2021-12-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 99 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 ABOUT 1 YEAR AFTER PRIMARY. THE PATIENT ALSO HAD A LOOSE STEM. IT IS UNKNOWN IF THE POTENTIAL INFECTION CAUSED THE LOOSENING. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATHOGEN INVOLVED IS STAPHYLOCOCCUS EPIDERMIDIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355913 MPACT ACETABULAR SHELL Ø50 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 166604 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention