BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø58 TWO-HOLES

    MDR report key: 7306122 · Received March 1, 2018

    Report

    Report Number
    3005180920-2018-00104
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    January 31, 2018
    Report Date
    March 1, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810893
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 FEBRUARY 2018 LOT 165901: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 DECEMBER 2016. EXPIRATION DATE: 2021-12-04 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. FLAT PE HC LINER Ø36/F REFERENCE 01.32.3648HCT (K103721) LOT 171741: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 SEPTEMBER 2017. EXPIRATION DATE: 2022-09-03 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. AMISTEM H HA COATED STD STEM SIZE 7 REFERENCE 01.18.137 (K093944) LOT 141474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JULY 2014. EXPIRATION DATE: 2019-05-31 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 REFERENCE 01.29.210 (K112115) LOT 162735: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 JULY 2016. EXPIRATION DATE: 2021-07-19 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. DUE TO THIS SIGN OF POSSIBLE INFECTION (PATHOGEN UNKNOWN), THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED A SPACER. IN ADDITION TO THE INFECTION, THE PATIENT HAD DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151335 MPACT ACETABULAR SHELL Ø58 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 165901 07630030810893

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention