BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT 3DMETAL ACETABULAR SHELL 48 TWO-HOLE

    MDR report key: 10331239 · Received July 28, 2020

    Report

    Report Number
    3005180920-2020-00456
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    June 29, 2020
    Report Date
    July 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812576
    PMA / PMN Number
    K171966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 10 JULY 2020: LOT 1810873: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2019. EXPIRATION DATE: 2024-01-06. 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. OTHER DEVICE INVOLVED IN THE EVENT: BALL HEADS: COCR 01.25.022 COCR BALL HEAD 12/14 Ø 32 SIZE M 0 LOT. 1811283 (K072857). BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 10 JULY 2020: LOT 1811283: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-27. 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 9MONTHS AFTER THE PRIMARY SURGERY REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE CUP AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE IS NO INFORMATION ABOUT ANY IMPLANT MOBILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795428 CUP: MPACT 3DMETAL ACETABULAR SHELL 48 TWO-HOLE ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 1810873 07630030812576

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention