BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS

    MDR report key: 7944948 · Received October 8, 2018

    Report

    Report Number
    0001822565-2018-05553
    Event Type
    Injury
    Date Received
    October 8, 2018
    Report Date
    February 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK091508
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00885101032, ITEM NAME: NEUTRAL LINER 32 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL, LOT #: 62720420. ITEM NUMBER: 00877503202, ITEM NAME: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14, LOT #: 2772592. ITEM NUMBER: 0106010106, ITEM NAME: AVENIR® MÃLLER, STEM, LATERAL, UNCEMENTED, HA, 6, TAPER 12/14, LOT #: 4023582. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 05554. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT IS EXPERIENCING PAIN APPROXIMATELY 3 YEARS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785029 SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 62939160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other