BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

    MDR report key: 11284531 · Received February 5, 2021

    Report

    Report Number
    3005180920-2021-00088
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    December 8, 2020
    Report Date
    February 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802058
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JANUARY 2021: LOT 092047: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2009. EXPIRATION DATE: 2014-08-31. 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 IMPLANT INVOLVED: CUP: VERSAFITCUP 01.26.54MB ACETABULAR SHELL Ø 54 (K083116) LOT. 092877. BATCH REVIEW PERFORMED ON 15 JANUARY 2021: LOT 092877: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2010. EXPIRATION DATE: 2015-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: VERSAFITCUP DM 01.26.2854M DOUBLE MOBILITY LINER Ø 54/28 (K083116) LOT. 092875. BATCH REVIEW PERFORMED ON 15 JANUARY 2021: LOT 092875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2010. EXPIRATION DATE: 2014-11-30. 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

    REVISION SURGERY ABOUT 10 YEARS AND 9 MONTHS AFTER PRIMARY FOR STEM LOOSENING AND HIGH LEVEL OF SUSPICION OF CUP LOOSENING WITH ECCENTRIC POLYETHYLENE ABRASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181190 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.024 092047 07630030802058

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention