BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL CC Ø 54

    MDR report key: 6525622 · Received April 27, 2017

    Report

    Report Number
    3005180920-2017-00210
    Event Type
    Injury
    Date Received
    April 27, 2017
    Report Date
    April 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 24 APRIL 2017. LOT 140067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MAY 2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP ACETABULAR SHELL Ø 58, CODE 01.26.58MB, LOT. 148346 (K083116), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MARCH 2015. EXPIRATION DATE: 2020-02-29. 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. DOUBLE MOBILITY HC LINER Ø 58/28, CODE 01.26.2858MHC, LOT. 131723 (K092265), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JUNE 2013. EXPIRATION DATE: 2018-04-30. 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. DOUBLE MOBILITY HC LINER Ø 54/28, CODE 01.26.2854MHC, LOT. 133946 (K092265), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 NOVEMBER 2013. EXPIRATION DATE: 2018-09-30. 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 DUE TO SIGNS OF INFECTION. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE DATE IN WHICH THE HARDWARE WAS REMOVED IS UNKNOWN. ON (B)(6) 2015 THE PATIENT CAME IN FOR THE SECOND PART OF THE STEP-WISE REVISION. THE SURGEON REMOVED THE SPACER AND IMPLANTED ANOTHER MEDACTA CUP AND LINER WITH NON-MEDACTA STEM AND HEAD. THE PATIENT CAME IN AGAIN DUE TO SIGNS OF INFECTION. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE DATE IN WHICH MEDACTA HARDWARE WAS REMOVED IS UNKNOWN. ON (B)(6) 2017 THE SURGEON REMOVED THE ANTIBIOTIC SPACER AND IMPLANTED A "LONG TERM ANTIBIOTIC SPACER." ON (B)(6) 2017 THE SURGEON IMPLANTED A MEDACTA STEM AND HEAD WITH NON-MEDACTA CUP AND LINER. THE SURGEON USED ANTIBIOTIC CEMENT AND ANTIBIOTIC BEADS. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE. THE PATHOGEN IS STAPH. AUREUS, NON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306592 VERSAFITCUP ACETABULAR SHELL CC Ø 54 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 140067

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention