BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 STD, SHORT NECK

    MDR report key: 5970048 · Received September 22, 2016

    Report

    Report Number
    3005180920-2016-00480
    Event Type
    Injury
    Date Received
    September 22, 2016
    Date of Event
    August 22, 2016
    Report Date
    December 28, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 SEPTEMBER 2016. LOT 132665: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 AUGUST 2013. EXPIRATION DATE: 2018-06-30. 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 60, CODE 01.26.60MB, LOT. 133929 (K083116), LOT 133929: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 OCTOBER 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. VERSAFITCUP DOUBLE MOBILITY HC LINER DIAM 60/28, CODE 01.26.2860MHC, LOT. 114609 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 FEBRUARY 2012. EXPIRATION DATE: 2017-01-31. 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 28 SIZE L +3.5, CODE 01.29.203, LOT. 134461 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 NOVEMBER 2013. EXPIRATION DATE: 2018-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 47 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 28 NOVEMBER 2016 AND INCLUDES: ON (B)(6) 2016 THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION HAS BEEN CONFIRMED. THE PATHOGEN IS STAPH. THE SURGEON REVISED THE STEM, HEAD, CUP AND LINER. THE SURGEON PLACE IN AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621476 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 STD, SHORT NECK CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 132665

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention