BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    MDR report key: 12809543 · Received November 15, 2021

    Report

    Report Number
    3005180920-2021-00894
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    October 21, 2021
    Report Date
    November 15, 2021
    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 · 0

    BATCH REVIEW PERFORMED ON 02.NOV.2021: LOT 2008060: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2021. EXPIRATION DATE: 2025-12-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO SIMILAR REPORTED EVENT. ADDITONAL IMPLANT INVOLVED: LINER: MPACT DM 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD (K092265) LOT. 2009650. BATCH REVIEW PERFORMED ON 02.NOV.2021: LOT 2009650: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2020. EXPIRATION DATE: 2025-11-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO SIMILAR REPORTED EVENT. ADDITONAL IMPLANT INVOLVED: STEM: AMISTEM-P COLLARED 01.18.432 AMISTEM-P COLLARED STD STEM SIZE 2 (K173794) LOT. 2011562. BATCH REVIEW PERFORMED ON 02.NOV.2021: LOT 2011562: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2021. EXPIRATION DATE: 2026-01-27 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO SIMILAR REPORTED EVENT. ADDITONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.243A SLEEVE SIZE XL (K131518) LOT. 2007618. BATCH REVIEW PERFORMED ON 02.NOV.2021: LOT 2007618: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 6-NOV-2020. EXPIRATION DATE: 2025-10-13 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO SIMILAR REPORTED EVENT. ADDITONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.230H HEAD BIOLOX OPTION Ø 28 (K131518) LOT. 2012928. BATCH REVIEW PERFORMED ON 02.NOV.2021: LOT 2012928: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2021. EXPIRATION DATE: 2026-04-05 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714040 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 CEMENTLESS ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.148MB 2008060 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention