BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT 01.26.2244MHC DOUBLE MOBILITY HC LINER 22.2/DMB

    MDR report key: 18111194 · Received November 10, 2023

    Report

    Report Number
    3005180920-2023-00863
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030806803
    PMA / PMN Number
    K131458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 OCTOBER 2023. LOT 2206939: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2022. EXPIRATION DATE: 2027-04-22. 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: LINER: MPACT 01.32.3641CF DM CONVERTER TIN COATED D/DMB (K211891) LOT 2110381: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2021. EXPIRATION DATE: 2026-11-23. 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. BALL HEADS: COCR 01.25.124 COCR BALL HEAD 12/14 Ø 22 SIZE S -2,5 (K080885) LOT 1901497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2019. EXPIRATION DATE: 2024-06-25. 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

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER THAT THE PATIENT SUSTAINED WHILE DANCING. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939334 LINER: MPACT 01.26.2244MHC DOUBLE MOBILITY HC LINER 22.2/DMB HIP DOUBLE MOBILITY HC LINER LZO MEDACTA INTERNATIONAL SA 2206939 07630030806803

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention