BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLPE LINER STANDARD

    MDR report key: 7891621 · Received September 19, 2018

    Report

    Report Number
    0001822565-2018-05136
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    December 5, 2016
    Report Date
    April 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK990135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE WILL BE REPORTED UNDER DIFFERENT MANUFACTURING SITE. EVENT WILL BE REPORTED IN MFR 0002648920-2019-00315.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE WILL BE REPORTED UNDER DIFFERENT MANUFACTURING SITE. EVENT WILL BE REPORTED IN MFR 0002648920-2019-00315.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: M / L TAPER G2 MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED, ITEM# 00771301100, LOT 63161443; KINECTIV MODULAR NECK, ITEM# 00784803300, LOT 63151229; BIOLOX® DELTA, CERAMIC FEMORAL HEAD, ITEM# 00877503202, LOT 2801912; TM SHELL POROUS WITH CLUSTER HOLES, ITEM# 00620205022, LOT 63146874. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-05135 AND 0001822565-2018-05137. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND 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 PATIENT WAS REVISED DUE TO PAIN APPROXIMATELY 13 MONTHS POST INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733361 XLPE LINER STANDARD PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 63152961

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R