BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-S 01.12.005 CEMENTLESS, SAND BLASTED STD STEM SIZE 5

    MDR report key: 15470267 · Received September 23, 2022

    Report

    Report Number
    3005180920-2022-00710
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    August 23, 2022
    Report Date
    September 22, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030801860
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 AUGUST 2022. LOT 092607: 15 ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2010. EXPIRATION DATE: 2014-NOV-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 30 AUGUST 2022. BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857) LOT 100916: 60 ITEMS MANUFACTURED AND RELEASED ON 23-APR-2010. EXPIRATION DATE: 2015-MAR-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50 (K083116) LOT 101397: 39 ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2010. EXPIRATION DATE: 2015-JUN-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP DM 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø 50/28 (K092265) LOT 091555: 78 ITEMS MANUFACTURED AND RELEASED ON 29-JUL-2009. EXPIRATION DATE: 2014-MAY-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 12 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553525 STEM: QUADRA-S 01.12.005 CEMENTLESS, SAND BLASTED STD STEM SIZE 5 HIP STEM CEMENTLESS JDI MEDACTA INTERNATIONAL SA 01.12.005 092607 07630030801860

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention