BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIZE II CUP HA 56

    MDR report key: 10008666 · Received April 29, 2020

    Report

    Report Number
    3006946279-2020-00078
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    October 9, 2007
    Report Date
    July 22, 2020
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G4, G7, H2, H3, H4, H6 AN H10. THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A COMPLAINT EXTRACT WAS DONE REGARDING REVISION DUE TO LOOSENING: 1 COMPLAINT (1 PRODUCT), THIS ONE INCLUDED, HAS BEEN RECORDED ON ALIZEE II CUP HA 56, REFERENCE (B)(4), FROM (B)(6) 2017 TO (B)(6) 2020. 1 COMPLAINT (1 PRODUCT), THIS ONE INCLUDED, HAS BEEN RECORDED ON ALIZEE II CUP HA 56, REFERENCE (B)(4), BATCH 0000139560. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION (HIP, LEFT) DUE TO CUP LOOSENING, 9 MONTHS AFTER IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. THIS EVENT WAS REPORTED THROUGH NJR (NATIONAL JOINT REGISTRY - UK) REPORT: REVIEW THE PERFORMANCE OF IMPLANTS FOLLOWING A REVIEW OF THE DATA CONDUCTED IN (B)(6) 2019 ON AURA II : ON (B)(4) PRIMARIES SURGERIES, (B)(4) HAVE BEEN REVISED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - ALIZE ACETABULAR LINER 28 X 56MM, REFERENCE (B)(4), LOT 000202272. FEMORAL HEAD STAINLESS/STEEL 28MM MEDIUM, REFERENCE (B)(4), LOT 213872. AURA II HIP LEFT SIZE 6, REFERENCE (B)(4), LOT 00018956. FOREIGN REPORT SOURCE: (B)(6). THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION (HIP, LEFT) DUE TO CUP LOOSENING, 9 MONTHS AFTER IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472575 ALIZE II CUP HA 56 ACETABULUM PROSTHESIS JDI BIOMET FRANCE S.A.R.L. 0000139560

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R