BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC Ø32/D

    MDR report key: 12867575 · Received November 24, 2021

    Report

    Report Number
    3005180920-2021-00944
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    November 5, 2021
    Report Date
    November 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 NOVEMBER 2021: LOT 2100154: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2021. EXPIRATION DATE: 2026-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 19 NOVEMBER 2021: BALL HEADS: MECTACER 01.29.231H HEAD BIOLOX OPTION Ø 32 (K131518) LOT 2006706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-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. CUP: MPACT 01.32.150SH ACETABULAR SHELL Ø50 NO-HOLE (K132879) LOT 2012948: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-APR-2021. EXPIRATION DATE: 2026-03-21. 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. STEM: MASTERLOC 01.39.009 CEMENTLESS TI COATED STD STEM SIZE 9 (K151531) LOT 166772A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2020. EXPIRATION DATE: 2025-04-27. 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 01.29.242A SLEEVE SIZE L (K131518) LOT 2006675: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-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 · 0

    THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767068 LINER: MPACT FLAT PE HC Ø32/D ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 01.32.3241HCT 2100154 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention