BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTRAL LINER 40 MM I.D. SIZE LL FOR USE WITH 58 MM O.D. SIZE LL SHELL

    MDR report key: 7413097 · Received April 10, 2018

    Report

    Report Number
    0001822565-2018-02068
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    June 20, 2017
    Report Date
    May 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQG
    PMA / PMN Number
    PK120370
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 00875700001 DOME HOLE PLUG SINGLE PACK 63543998; 00625006540 BONE SCR 6.5X40 SELF-TAP 63523411; 00625006525 BONE SCR 6.5X25 SELF-TAP 63530642; S991140 SELEX/MAGNUM MOD HD 40MM +9 770680; 00625006520 BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH 63540344; 00625006530 BONE SCR 6.5X30 SELF-TAP 63540364; 00875705802 SHELL WITH MULTI HOLES POROUS 58 MM O.D. SIZE LL FOR USE WITH LL LINERS LOT # 63301666. EVENT WAS CONFIRMED BY MEDICAL RECORDS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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.

    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. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # S991140, FEMORAL HEAD, LOT # 770680. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-02068, 0001825034-2018-02447.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257114 NEUTRAL LINER 40 MM I.D. SIZE LL FOR USE WITH 58 MM O.D. SIZE LL SHELL HIP PROSTHESIS OQG ZIMMER BIOMET, INC. N/A 63350257

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R