BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/G

    MDR report key: 12433068 · Received September 7, 2021

    Report

    Report Number
    3005180920-2021-00708
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    August 9, 2021
    Report Date
    September 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812156
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2021: LOT 2003336: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2020. EXPIRATION DATE: 2025-06-29. 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 ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2021. CUP: MPACT 3DMETAL 01.38.060DH ACETABULAR SHELL Ø60 TWO-HOLE (K171966) LOT. 2010341. LOT 2010341: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-FEB-2021. EXPIRATION DATE: 2026-02-15. 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 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2009406. LOT 2009406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2021. EXPIRATION DATE: 2026-01-12. 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. STEM: SMS SOLID 01.36.051 SMS SOLID STEM STD SIZE 11 (K181693) LOT. 2004949. LOT 2004949: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2020. EXPIRATION DATE: 2025-10-04. 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. SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 (K103721) LOT. 2010033. LOT 2010033: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2020. EXPIRATION DATE: 2025-10-29. 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, REMOVED ALL HARDWARE, AND IMPLANTED NEW HARDWARE 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332946 LINER: MPACT FLAT PE HC LINER 36/G HIP FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3652HCT 2003336 07630030812156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention