BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø36/G

    MDR report key: 14684583 · Received June 14, 2022

    Report

    Report Number
    3005180920-2022-00463
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 18, 2022
    Report Date
    June 14, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040731119
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 MAY 2022. LOT 1810852: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2019. EXPIRATION DATE: 2024-MAR-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 24 MAY 2022. BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT. 2012925. LOT 2012925: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2021. EXPIRATION DATE: 2026-MAR-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. STEM: AMISTEM P 01.18.408 AMISTEM-P STD STEM SIZE 8 (K173794) LOT. 179943. LOT 179943: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2018. EXPIRATION DATE: 2023-APR-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CUP: MPACT 01.32.160DH ACETABULAR SHELL Ø60 TWO-HOLES (K132879) LOT. 2001289. LOT 2001289: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2020. EXPIRATION DATE: 2025-JUN-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2814416 LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø36/G FACE-CHANGING PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3652HC10A 1810852 07630040731119

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention