BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    MDR report key: 8230876 · Received January 9, 2019

    Report

    Report Number
    3005180920-2018-01082
    Event Type
    Injury
    Date Received
    January 9, 2019
    Date of Event
    December 13, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JANUARY 2019: LOT 176383: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2018. EXPIRATION DATE: 26-12-2022. 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 EXPLANTED: LINER: MPACT 01.32.3644HCAT HOODED PE HC LINER Ø36/E (K132879), LOT 176973: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2018. EXPIRATION DATE: 14.02.2023 . 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. STEM: MASTERLOC 01.39.208 CEMENTLESS TI COATED LAT STEM # 8 (K151531), LOT 163572: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2016 . EXPIRATION DATE: 2021-07-11. 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. CUP: MPACT 01.32.154DH ACETABULAR SHELL Ø54 TWO-HOLES (K132879), LOT 176952: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2018. EXPIRATION DATE: 06.02.2023. 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

    THE PATIENT CAME IN, 7 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS STAPHYLOCOCCUS EPIDERMIS. THE SURGEON REMOVED THE CUP, LINER, HEAD AND STEM AND WASHED THE HIP OUT. ANIBIOTIC SPACERS WERE IMPLANTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24770 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 176383 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention