BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER NEUTRAL 36 MM I.D. SIZE NN FOR USE WITH 62 MM O.D. SIZE NN SHELL

    MDR report key: 8549388 · Received April 25, 2019

    Report

    Report Number
    0001822565-2019-01731
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    March 29, 2019
    Report Date
    July 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. PROVIDED PHOTOGRAPH INDICATES SCRATCHES ON THE SURFACE OF RETURNED HEAD. THE LINER HAD A SCREW ATTACHED TO THE ARTICULATING SURFACE LIKELY USED TO EXPLANT THE DEVICE. BLOOD STAINS ARE NOTED ON BOTH THE DEVICES. NO FURTHER EVALUATION CAN BE PERFORMED USING THE RETURNED PHOTOGRAPH. 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). CONCOMITANT MEDICAL PRODUCTS: ITEM# 00784802300 MODULAR NECK G 12/14 NECK TAPER USE WITH +0 HEADS ONLY LOT# 64052234. ITEM# 00877503602 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14 LOT# 2971132. ITEM# 00771301600 MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 16.25 LOT# 64079447. 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 PATIENT UNDERWENT REVISION FOR DISLOCATION AND PAIN APPROXIMATELY 55 DAYS POST INITIAL IMPLANTATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346614 LINER NEUTRAL 36 MM I.D. SIZE NN FOR USE WITH 62 MM O.D. SIZE NN SHELL PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 64003408

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R