BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28

    MDR report key: 11831972 · Received May 17, 2021

    Report

    Report Number
    3005180920-2021-00387
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    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 30 APRIL 2021: LOT 2006366: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-AUG-2020. EXPIRATION DATE: 2025-07-21. 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 DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 30 APRIL 2021: CUP: MPACT 01.32.150MB DOUBLE MOBILITY ACETABULAR SHELL ¿50 (K143453) LOT 2006087: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2020. EXPIRATION DATE: 2025-10-12. 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-P 01.12.121 QUADRA-P STD STEM SIZE 1 (K181254) LOT 2002666: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2020. EXPIRATION DATE: 2025-07-20. 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. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 ¿ 28 SIZE M 0 (K112115) LOT 2006678: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-OCT-2020. EXPIRATION DATE: 2025-09-24. 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.

    Description of Event or Problem · 1

    1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS STAPHYLOCOCCUS AUREUS. 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
    733083 VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28 HIP SHELL LINER MEH MEDACTA INTERNATIONAL SA 01.26.2850MHC 2006366 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention