BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERLOC CEMENTLESS TI COATED STEM SIZE 11 LAT

    MDR report key: 6310742 · Received February 8, 2017

    Report

    Report Number
    3005180920-2017-00024
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 6, 2017
    Report Date
    February 8, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 07 FEBRUARY 2017. LOT 162773: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JUNE 2016. EXPIRATION DATE: 2021-05-23. 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 HEAD BIOLOX OPTION Ø 28, CODE 01.29.230H, LOT. 167065 (K131518) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2016. EXPIRATION DATE: 2021-11-14. 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. MECTACER SLEEVE SIZE M, CODE 01.29.241A, LOT. 153578 (K131518) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 DECEMBER 2015. EXPIRATION DATE: 2020-12-07. 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. DOUBLE MOBILITY HC LINER Ø 58/28, CODE 01.26.2858MHC, LOT. 157126 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 FEBRUARY 2016. EXPIRATION DATE: 2021-02-06. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION IS CONFIRMED AS STAPH. THE SURGEON REVISED THE HEAD, SLEEVE, LINER AND STEM. THE SURGEON LEFT THE CUP IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95367 MASTERLOC CEMENTLESS TI COATED STEM SIZE 11 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 162773

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention