BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D

    MDR report key: 16655188 · Received March 31, 2023

    Report

    Report Number
    3005180920-2023-00217
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    March 3, 2023
    Report Date
    March 31, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30-MAR-2023. LOT 2111802: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2021. EXPIRATION DATE: 2026-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT 2108568: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2021. EXPIRATION DATE: 2026-09-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 9 MONTHS AND 1 WEEK THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE CUP, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059648 LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D HIP FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3241HCT 2111802 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention