BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH

    MDR report key: 16156630 · Received January 13, 2023

    Report

    Report Number
    3005180920-2023-00003
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 29, 2022
    Report Date
    January 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 JANUARY 2023: LOT 2104156: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2021. EXPIRATION DATE: 2026-06-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 03 JANUARY 2023: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 2203050 LOT 2203050: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2022. EXPIRATION DATE: 2027-04-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. STEM: QUADRA-P 01.12.124 QUADRA-P STD STEM SIZE 4 (K181254) LOT. 2117662 LOT 2117662: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2022. EXPIRATION DATE: 2027-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. CUP: MPACT 01.32.156MB DOUBLE MOBILITY ACETABULAR SHELL Ø56 (K143453) LOT. 2111694 LOT 2111694: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2022. EXPIRATION DATE: 2027-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF A STAPHYLOCOCCUS INFECTION AND THE CAUSE IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017962 LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH DOUBLE MOBILITY HIP LINER MEH MEDACTA INTERNATIONAL SA 01.26.2856MHC 2104156 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention