BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LZOVERSAFITCUP CC TRIO NO HOLE CUP

    MDR report key: 8211949 · Received January 3, 2019

    Report

    Report Number
    3005180920-2018-01054
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    November 27, 2018
    Report Date
    January 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807893
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON 20TH DEC 2018 THE R&D PROJECT MANAGER VISUALLY CHECKED THE "RETRIVED" IMPLANT: VISUAL INSPECTION HIGHLIGHTS BONE RESIDUALS ON THE CUP EXTERNAL SURFACE. SIGNS OF EXTRACTION, COATING LOSS ON THE EQUATORIAL SIDE. THE COATING DETACHED FROM THE POLAR ZONE DURING EXTRACTION, THAT REMAINED ANCHORED TO THE ACETABULAR BONE, MAY HIGHLIGHT THAT GOOD "OSTEOINTEGRATION" WAS IN PROCESS. PROBABLY DURING EXTRACTION, THE OSTEOTOME DETERMINED THE DETACHMENT OF THE COATING FROM THE CUP. BATCHES REVIEW PERFORMED ON 03 JANUARY 2019: LOT 179143: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 APRIL 2018. EXPIRATION DATE: 2023-03-26. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP CC PE LINER CODE 01.26.3244HCT LOT. 179308 (K103352): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 APRIL 2018. EXPIRATION DATE: 2023-03-20. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S - CODE 01.29.204 LOT. 177688 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 APRIL 2018. EXPIRATION DATE: 2023-04-05. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. AMISTEM-H PROXIMAL COATING STD STEM #5 CODE 01.18.175 LOT. 180062 (K161635): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MAY 2018. EXPIRATION DATE: 2023-04-26. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    A FEW MONTH AFTER THE UNDERTAKEN PRIMARY THA, THE PATIENT WAS COMPLAINING ABOUT REMAINING PAIN. AFTER INVESTIGATION A LOW-GRADE INFECTION WAS DIAGNOSED (STAPH EPIDERMITIS). ON (B)(6) 2018, ALL PRIMARY HIP COMPONENTS HAVE BEEN REVISED. DURING THE EXPLANTATION A CHISEL WAS USED ON THE LATERAL SIDE IN ORDER TO RELEASE THE CUP; SOME HA COATING REMAINED IN THE ACETABULUM WHICH COULD BE REMOVED AFTERWARDS. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7531 LZOVERSAFITCUP CC TRIO NO HOLE CUP ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 179143 07630030807893

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention