BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 028/ 0MM

    MDR report key: 8821580 · Received July 24, 2019

    Report

    Report Number
    3002806535-2019-00617
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    April 28, 2015
    Report Date
    July 24, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: BIHAPRO SHELL HA/PC 52MM LN 23, CATALOG #: 165743, LOT #: 1170828; MEDICAL PRODUCT: BIHAPRO MK III HA/PC SZ6 LH T1, CATALOG #: 12-164566, LOT #: 124027; MEDICAL PRODUCT: BIHAPRO FEM PMMA CNTRLZR 13MM, CATALOG #: 164204, LOT #: 1343577; MEDICAL PRODUCT: ARCOM 28MM RNGLOC LNR HWALL 23, CATALOG #: 11-105903, LOT #: 2009020675. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00564, 3002806535-2019- 00618, 3002806535-2019-00619, 3002806535-2019-00620. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. ROOT CAUSE 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON DUE TO AVASCULAR HIP NECROSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614329 DELTA CERAMIC FEM HD 028/ 0MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A 1673301

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention