BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER ELEVATED RIM 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL

    MDR report key: 8129723 · Received December 4, 2018

    Report

    Report Number
    0001822565-2018-06690
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    October 29, 2018
    Report Date
    July 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K093846
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MODEL #: (01) 00889024149724 (17)230531 (10)64056167. ITEM# UNKNOWN. UNKNOWN SHELL. LOT# UNKNOWN. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF VISUAL INSPECTION OF THE DEVICE IDENTIFIED DAMAGE TO THE SCALLOPS AND LOCKING FEATURE AS WELL AS GOUGES, NICKS, AND SCRATCHES THAT WERE THE RESULT OF THE ATTEMPTED IMPLANTATION. INDENTATIONS AND DEFORMITIES WERE PRESENT ON THE UNDERSIDE OF MULTIPLE SCALLOPS, CONFIRMING THE REPORTED EVENT. NO DIMENSIONAL ANALYSIS WAS PERFORMED DUE TO THE EXTENT OF THE DAMAGE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    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. 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 THAT THE LINER WOULD NOT SEAT WITH THE CUP AFTER TRYING TO IMPACT A FEW TIMES BY THE SURGEON. A NEW LINER WAS USED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971437 LINER ELEVATED RIM 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL PROSTHESIS HIP JDI ZIMMER BIOMET, INC. N/A 64056167

    Patients

    Seq Age Sex Outcome Treatment
    1