BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48

    MDR report key: 10354778 · Received August 3, 2020

    Report

    Report Number
    3005180920-2020-00489
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    July 3, 2020
    Report Date
    August 3, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860959
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 JULY 2020: LOT 1909298: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2020. EXPIRATION DATE: 2025-03-09. 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 IMPLANT INVOLVED: LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER 48/28 (K092265) LOT. 1909376 BATCH REVIEW PERFORMED ON 22 JULY 2020 LOT 1909376: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29JAN2020. EXPIRATION DATE: 2025-01-13. 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 IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE M 0 (K112115) LOT. 1906462 BATCH REVIEW PERFORMED ON 22 JULY 2020: LOT 1906462: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: STEM: AMISTEM P 01.18.399 AMISTEM-P STD STEM SIZE 00 (K173794) LOT. 1900059. BATCH REVIEW PERFORMED ON 22 JULY 2020: LOT 1900059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2019. EXPIRATION DATE: 2024-04-07. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL COMPONENTS 1 MONTH AFTER PRIMARY. AN ANTIBIOTIC SPACER WAS IMPLANTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821891 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48 ACETABULAR CUP DOUBLE MOBILITY LPH MEDACTA INTERNATIONAL SA 01.32.148MB 1909298 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention