BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5

    MDR report key: 9909610 · Received April 1, 2020

    Report

    Report Number
    3005180920-2020-00197
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802065
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 MARCH 2020: LOT 180186: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2018. EXPIRATION DATE: 2023-05-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: CUP: MPACT 01.32.156SH ACETABULAR SHELL 56 NO-HOLE LOT. 165753 (K132879) BATCH REVIEW PERFORMED ON 09 MARCH 2020: LOT 165753: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2016. EXPIRATION DATE: 2021-11-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3248HCT FLAT PE HC LINER 32/F (K103721) BATCH REVIEW PERFORMED ON 09 MARCH 2020: LOT 180651: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2018. EXPIRATION DATE: 2023-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE L +4 (K112115) BATCH REVIEW PERFORMED ON 09 MARCH 2020 LOT 177696: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2018. EXPIRATION DATE: 2023-03-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT HAD ORIGINAL ANTERIOR HIP REPLACEMENT ON (B)(6) 2018, NO ISSUES UNTIL 3 MONTHS AGO, WHEN HE RETURNED TO DR WITH PAIN. AFTER XRAY'S AND BIOPSY, INFECTION WAS CONFIRMED IN FEMUR. ALL IMPLANTS REMOVED 1 YEAR AND A HALF AFTER PRIMARY FOR STAGE 1 REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374223 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.025 180186 07630030802065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention