BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48

    MDR report key: 10238597 · Received July 7, 2020

    Report

    Report Number
    3005180920-2020-00396
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860959
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 JUNE 2020: LOT 183906: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2018. EXPIRATION DATE: 2023-08-19. 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. ADDITIONA DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 16 JUNE 2020: LINER: MPACT DM 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD (K092265) LOT 1901454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2019. EXPIRATION DATE: 2024-05-12. 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. BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115). LOT 1810791: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2019. EXPIRATION DATE: 2024-02-19. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. ON (B)(6) 2019, THE SURGEON REVISED THE STEM, HEAD AND LINER. PRESENTLY (1 YEAR AFTER PREVIOUS SURGERY), THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702711 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48 HIP ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.148MB 183906 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention