BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S

    MDR report key: 8615709 · Received May 16, 2019

    Report

    Report Number
    3005180920-2019-00377
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 16, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809125
    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 13 MAY 2019. LOT 186530: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2018. EXPIRATION DATE: 2023-11-07. 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. ADDITIONAL IMPLANTS INVOLVED: LINER: MPACT 01.26.2854MHC DOUBLE MOBILITY HC LINER 28/DMG (K092265), LOT 186325: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2018. EXPIRATION DATE: 2023-09-23. 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. CUP: MPACT 01.32.154MB DOUBLE MOBILITY ACETABULAR SHELL Ø54 (K143453), LOT 184746: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2018. EXPIRATION DATE: 2023-10-04. 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. STEM: QUADRA-H 01.12.24SN CEMENTLESS, HA COATED STD STEM SIZE 4, SHORT NECK (K093944), LOT 187009: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-28. 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 15 DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP IMPLANTS FOR AN INFECTION (THE PATHOGEN IS UNKNOWN). ALL HARDWARE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410183 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 186530 07630030809125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention