BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL 56 TWO-HOLES

    MDR report key: 10703211 · Received October 20, 2020

    Report

    Report Number
    3005180920-2020-00727
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 20, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810855
    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 02 OCTOBER 2020: LOT 160031: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2016. EXPIRATION DATE: 2021-03-31. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 02 OCTOBER 2020: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 162732: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUL-2016. EXPIRATION DATE: 2021-07-19. 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, 3 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE CUP AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170664 MPACT ACETABULAR SHELL 56 TWO-HOLES HIP UNCEMENTED SHELL LPH MEDACTA INTERNATIONAL SA 01.32.156DH 160031 07630030810855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention