BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 13839894 · Received March 21, 2022

    Report

    Report Number
    3005180920-2022-00198
    Event Type
    Injury
    Date Received
    March 21, 2022
    Date of Event
    February 25, 2022
    Report Date
    March 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 MARCH 2022. LOT 172860: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2017. EXPIRATION DATE: 2022-08-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018. ADDITIONAL COMPONENTS INVOLVED: STEM: QUADRA-H 01.12.20SN CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK (K082792) LOT. 189855: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2019. EXPIRATION DATE: 2024-01-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: MPACT 01.32.2837HCT FLAT PE HC LINER Ø28/B (K103721) LOT. 176961: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MARCH-2018. EXPIRATION DATE: 2023-02-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CUP: MPACT 01.32.146DH ACETABULAR SHELL Ø46 TWO-HOLES (K132879) LOT. 182585: (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 SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED DUE TO INFECTION 2 YEARS 2 MONTHS AFTER THE PRIMARY SURGERY. ALL IMPLANTS WERE REMOVED AND REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35920 BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0 HIP BALL HEAD COCR JDI MEDACTA INTERNATIONAL SA 01.25.012 172860 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention