BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES

    MDR report key: 9580028 · Received January 13, 2020

    Report

    Report Number
    3005180920-2019-01138
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    December 15, 2019
    Report Date
    January 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810855
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 DECEMBER 2019. LOT 1811191: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2019. EXPIRATION DATE: 2024-04-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 LOT. 1900806 (K112115). BATCH REVIEW PERFORMED ON 17 DECEMBER 2019. LOT 1900806: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: IMPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F LOT. 184754 (K103721). BATCH REVIEW PERFORMED ON 17 DECEMBER 2019. LOT 184754: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-SEP-2018. EXPIRATION DATE: 2023-08-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 2 OTHER SIMILAR REPORTED EVENTS.

    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 REMOVED THE CUP, HEAD AND LINER 7 WEEKS AFTER PRIMARY. A NEW HEAD AND LINER WERE CEMENTED IN PLACE TO ACT AS A TEMPORARY SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46292 CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 1811191 07630030810855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention