BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5

    MDR report key: 7637642 · Received June 26, 2018

    Report

    Report Number
    3005180920-2018-00463
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 26, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805103
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 JUNE 2018. LOT 174664: ITEMS MANUFACTURED AND RELEASED ON 22 NOVEMBER 2017. EXPIRATION DATE: 2022-11-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 79 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED AMISTEM H 01.18.232(K121011), STEM COLLARED HA COATED STD STEM #2 L. LOT 172623: 47 ITEMS MANUFACTURED AND RELEASED ON 28 AUGUST 2017. EXPIRATION DATE: 2022-08-17 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 43 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT DOUBLE MOBILITY HC LINER 28/DMH REFERENCE (B)(4). LOT 174325: 40 ITEMS MANUFACTURED AND RELEASED ON 27 NOVEMBER 2017. EXPIRATION DATE: 2022-11-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56 REFERENCE (B)(4). LOT 176090: 40 ITEMS MANUFACTURED AND RELEASED ON 27 NOVEMBER 2017. EXPIRATION DATE: 2023-01-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR HIP PAIN. THE REASON OF PAIN IS UNKNOWN, ALL THE IMPLANTS WERE SWAPPED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481592 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 174664 07630030805103

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention