BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT OFFSET 4MM PE HC LINER 32/E

    MDR report key: 10526942 · Received September 14, 2020

    Report

    Report Number
    3005180920-2020-00619
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    August 21, 2020
    Report Date
    February 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040730839
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 22ND 2021 WE HAVE RECEVIED THE FOLLOWING INFORMATON: THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2020: LOT 1810833:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2019. EXPIRATION DATE: 2024-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2020: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115), LOT 1810833: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(4) 2019. EXPIRATION DATE: 2024-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE HIP JOINT DISLOCATED ANTERIORLY. THE SURGEON DECIDED TO PERFORM A CLOSED REDUCTION UNDER ANESTHESIA BUT THE PATIENT'S HIP DID NOT REMAIN STABLE. THE SURGEON DECIDED TO OPEN UP THE PATIENT AND REVISE THE HEAD AND LINER FOR STABILITY 2 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993894 LINER: MPACT OFFSET 4MM PE HC LINER 32/E HIP SHELL LINER LPH MEDACTA INTERNATIONAL SA 01.32.3244HC4 1810833 07630040730839

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R