BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    MDR report key: 9237118 · Received October 25, 2019

    Report

    Report Number
    3005180920-2019-00906
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    July 4, 2019
    Report Date
    October 25, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860959
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 OCTOBER 2019. LOT 185972: 20 ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2018. EXPIRATION DATE: 2023-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 19 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 09 OCTOBER 2019. STEM: QUADRA-C 01.12.051 CEMENTED, MIRROR POLISHING LAT STEM SIZE 1 12/14 (K083558) LOT. 175306 LOT 175306: 24 ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2017. EXPIRATION DATE: 2022-09-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. IMPACT 01.33.101 MECTAPLUG PE SIZE 1 LOT. 1811301 (ITEM NOT REGISTERED IN USA). LOT 1811301: 209 ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2019. EXPIRATION DATE: 2024-03-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 187 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 189636. LOT 189636: 240 ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2019. EXPIRATION DATE: 2024-02-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 186 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 3 OTHER SIMILAR REPORTED EVENT. LINER: IMPACT DM 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD (K092265) LOT. 186322. LOT 186322: 168 ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2018. EXPIRATION DATE: 2023-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 148 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION FOLLOWING A SUSPICION OF INFECTION. ALL IMPLANTS HAVE BEEN REVISED EXCEPT THE CUP 3 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036748 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 185972 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention