BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE

    MDR report key: 10301337 · Received July 21, 2020

    Report

    Report Number
    3005180920-2020-00439
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 24, 2020
    Report Date
    July 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810862
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 JULY 2020: LOT 1904343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AGO-2019. EXPIRATION DATE: 2024-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F LOT. 1903450 (K103721). BATCH REVIEW PERFORMED ON 06 JULY 2020: LOT 1903450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2019. EXPIRATION DATE: 2024-05-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 LOT. 1907360 (K112115). BATCH REVIEW PERFORMED ON 06 JULY 2020: LOT 1907360: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2020. EXPIRATION DATE: 2025-01-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. STEM: SMS SOLID 01.36.047 SMS SOLID STEM STD #7 LOT. 1908704 (K181693). BATCH REVIEW PERFORMED ON 03 JULY 2020: LOT 1908704: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769821 CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.156MH 1904343 07630030810862

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention