BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 19566390 · Received June 19, 2024

    Report

    Report Number
    3005180920-2024-00439
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 24, 2024
    Report Date
    October 3, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 JUNE 2024. LOT 2244991: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2023. EXPIRATION DATE: 2028-02-06. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICES INVOVLED. BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2024. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2200870: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2022. EXPIRATION DATE: 2027-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2306406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2023. EXPIRATION DATE: 2028-04-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. UPDATED DEVICE SALES. CUP: MPACT 01.32.154DH ACETABULAR SHELL Ø54 TWO-HOLES (K132879) LOT 2244991: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2023. EXPIRATION DATE: 2028-02-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 9 MONTHS POST PRIMARY DURING A CT SCAN CONTROL THE SURGEON NOTICED SOME POINTS ON THE SHELL WHERE THE BONE IS NOT GROWING. NO REVISION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705139 MPACT ACETABULAR SYSTEM HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.154DH 2244991 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other