BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6

    MDR report key: 10689733 · Received October 16, 2020

    Report

    Report Number
    3005180920-2020-00714
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802072
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 SEPTEMBER 2020: LOT 091218: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AUG-2009. EXPIRATION DATE: 2014-05-31. 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. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 28 SEPTEMBER 2020: IMPLANTS FROM CERAMTEC 38.39.7175.245.00 BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (USA) (K073337) LOT. 092498 LOT 092498: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2009. EXPIRATION DATE: 2014-12. 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. LINER: VERSAFITCUP DM 01.26.2856M DOUBLE MOBILITY LINER 28/DMH (K083116) LOT. 090257. LOT 090257: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2009. EXPIRATION DATE: 2014-03-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 11 YEARS AND 8 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE QUADRA H STD SIZE 6 STEM, FEMORAL HEAD AND DM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156821 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6 CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.026 091218 07630030802072

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention