BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG

    MDR report key: 9085573 · Received September 19, 2019

    Report

    Report Number
    3005180920-2019-00771
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    August 20, 2019
    Report Date
    September 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807381
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 AUGUST 2019: LOT 1810747: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-FEB-2019. EXPIRATION DATE: 2024-01-19. 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 IN THE EVENT, BATCH REVIEW PERFORMED ON 28 AUGUST 2019: BALL HEADS: MECTACER 01.29.230H HEAD BIOLOX OPTION Ø 28 (K131518) LOT. 189669. LOT 189669: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2019. EXPIRATION DATE: 2024-01-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.243A SLEEVE SIZE XL (K131518) LOT. 1810821 LOT 1810821: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2019. EXPIRATION DATE: 2024-02-24. 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 01.39.408 CEMENTLESS TI COATED LAT PLUS STEM SIZE 8 (K173267) LOT. 181502. LOT 181502: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2018. EXPIRATION DATE: 2023-05-24. 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. 1900194. LOT 1900194: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2019. EXPIRATION DATE: 2024-05-29. 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 HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. THE PATIENT SUBSEQUENTLY CAME IN ON (B)(6) 2019 DUE TO SIGNS OF AN INFECTION. THE PATHOGEN WAS UNKNOWN AND THE SURGEON (MD CRAIG BONE) REVISED THE HEAD, SLEEVE AND POLY, COMPLAINT (B)(4) [MDR 2019-00757] WAS FILLED. ON THE (B)(6) 2019 ABOUT 1 MONTH AFTER PRIMARY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON PLANS TO IMPLANT PERMANENT HARDWARE IN 6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884892 LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG HIP HC LINER MEH MEDACTA INTERNATIONAL SA 1810747 07630030807381

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention