BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 20154723 · Received September 6, 2024

    Report

    Report Number
    3005180920-2024-00684
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 AUG 2024 LOT 2204579: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2022. EXPIRATION DATE: 2027-05-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS REVISED BATCH REVIEW PERFORMED ON 08 AUG 2024 ON LINER: MECTACER 01.29.413 CERAMIC LINER Ø 36 / E LOT. 2218800 LOT 2218800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-OCT-2022. EXPIRATION DATE: 2027-10-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PRODUCT NOT MARKETED IN US. BATCH REVIEW PERFORMED ON 08 AUG 2024 ON BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2211909 LOT 2211909: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2022. EXPIRATION DATE: 2027-08-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED DUE TO ANTERIOR HIP PAIN AT 1 YEAR AND 6 MONTHS FROM THE PRIMARY. THE CUP, LINER AND HEAD WERE REMOVED AND REPLACED WITH A DUAL MOBILITY COMPETITOR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074010 CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES HIP ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 2204579 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention