BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT HOODED PE HC LINER Ø36/E

    MDR report key: 16004172 · Received December 19, 2022

    Report

    Report Number
    3005180920-2022-00976
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    December 9, 2022
    Report Date
    December 19, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812101
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 1900229: 50 ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2019. EXPIRATION DATE: 2024-03-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 48 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2206351: 198 ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2022. EXPIRATION DATE: 2027-05-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 174 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AND 2 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126382 LINER: MPACT HOODED PE HC LINER Ø36/E HIP ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCAT 1900229 07630030812101

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention