BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø50 MULTI-HOLE

    MDR report key: 8069019 · Received November 14, 2018

    Report

    Report Number
    3005180920-2018-00908
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810770
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2018: LOT 163607: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-SEP-2016. EXPIRATION DATE: 2021-08-31. 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 COMPONENTS REVISED: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D, LOT 177246: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2018. EXPIRATION DATE: 2023-02-04. 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. BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0, LOT 180534: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2018. EXPIRATION DATE: 2023-06-26. 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

    ABOUT 10 DAYS AFTER PRIMARY SURGERY, THE SURGEON REVISED THE PATIENT FOR AN INFECTION CASE. CUP, LINER AND BALL HEAD WERE SWAPPED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910611 CUP: MPACT ACETABULAR SHELL Ø50 MULTI-HOLE HIP SHELL CEMENTLESS LPH MEDACTA INTERNATIONAL SA 163607 07630030810770

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention