BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø54 MULTI-HOLE

    MDR report key: 8793456 · Received July 16, 2019

    Report

    Report Number
    3005180920-2019-00588
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    June 20, 2019
    Report Date
    July 16, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810831
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 2 JULY 2019: LOT 186958: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-"GEN"-2019. EXPIRATION DATE: 2024-01-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 2 JULY 2019: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E LOT 1811217 (K103721): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 1-MAR-2019. EXPIRATION DATE: 2024-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. STEM: AMISTEM P 01.18.443 AMISTEM-P COLLARED LAT STEM SIZE 3, LOT: 188032 (K173794): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-"DIC"-2018. EXPIRATION DATE: 2023-12-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0, LOT: 187086 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-"DIC"-2018. EXPIRATION DATE: 2023-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 9 DAYS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON EXPLANTED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586174 CUP: MPACT ACETABULAR SHELL Ø54 MULTI-HOLE ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 186958 07630030810831

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention