BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 0 12/14

    MDR report key: 9202083 · Received October 17, 2019

    Report

    Report Number
    3005180920-2019-00882
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    September 20, 2019
    Report Date
    October 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802218
    PMA / PMN Number
    K083558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02-OCT-2019. LOT 180193: 25 ITEMS MANUFACTURED AND RELEASED ON 18-APR-2018. EXPIRATION DATE: 08.04.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED IN THE EVENT: BALL HEADS: COCR 01.25.032 COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5 LOT. 155870 (K080885): BATCH REVIEW PERFORMED ON 02-OCT-2019. LOT 155870: 20 ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2016. EXPIRATION DATE: 16.12.2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: IMPACT 01.32.3652HCAT HOODED PE HC LINER Ø36/G LOT. 168491 (K132879): BATCH REVIEW PERFORMED ON 02-OCT-2019. LOT 168491: 60 ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2017. EXPIRATION DATE: 15.01.2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. SUBSEQUENTLY, ON (B)(6) 2018, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS IDENTIFIED AS STREPTOCOCCUS. THE SURGEON PERFORMED AN I&D AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT 1839-18 WAS FILED. ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND ALL IMPLANTS WERE EXPLANTED AND THE SURGEON IMPLANTED A HEAD, STEM, AND LINER WITH ANTIBIOTICS. PRESENTLY, ON (B)(6) 2019, THE PATIENT CAME IN TO HAVE PERMANENT HARDWARE IMPLANTED. THE SURGEON REMOVED THE MEDACTA HEAD, STEM, AND LINER THAT ACTED AS A SPACER AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999662 STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 0 12/14 HIP CEMENTED STEM LZO MEDACTA INTERNATIONAL SA 180193 07630030802218

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention