BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50

    MDR report key: 7344706 · Received March 16, 2018

    Report

    Report Number
    3005180920-2018-00156
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    February 14, 2018
    Report Date
    March 16, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860966
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 MARCH 2018: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50 REFERENCE: (B)(4) (K143453). LOT 175552: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 DECEMBER 2017; EXPIRATION DATE: 2022-12-05. NO ANOMALIES FOUND RELATED TO THE EVENT. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. MPACT DM DOUBLE MOBILITY HC LINER 28/DME REFERENCE: (B)(4) (K092265) LOT 174493: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 NOVEMBER 2017; EXPIRATION DATE: 2022-10-30 NO ANOMALIES FOUND RELATED TO THE EVENT. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. AMISTEM H COLLARED HA COATED STD STEM SIZE 0 REFERENCE (B)(4) (K121011) LOT 171633: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4 AUGUST 2017; EXPIRATION DATE: 2022-07-24. NO ANOMALIES FOUND RELATED TO THE EVENT. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 REFERENCE (B)(4) (K112115) LOT 172251: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 JULY 2017; EXPIRATION DATE: 2022-07-18. NO ANOMALIES FOUND RELATED TO THE EVENT. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REVISED ALL HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188804 MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50 DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 175552 07630030860966

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention