BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT

    MDR report key: 12589676 · Received October 7, 2021

    Report

    Report Number
    0001822565-2021-02803
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    October 22, 2019
    Report Date
    November 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K192660
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INITIAL SURGERY DOCUMENTATION WAS PROVIDED AND SHOWS NO INTRAOP COMPLICATIONS OCCURRED, AND THE PATIENT HAS ARTHRITIS AND OBESITY AS SIGNIFICANT PAST MEDICAL HISTORY. ROOT CAUSE REMAINS UNCHANGED. 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 · 0

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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 ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00801803601- FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER- 61587762. 00875705602- SHELL WITH MULTI HOLES POROUS 56 MM O.D. SIZE KK FOR USE WITH KK LINERS- 61762747. 00875101236- NEUTRAL LINER 36 MM I.D. SIZE KK FOR USE WITH 56 MM O.D. SIZE KK SHELL- 61762747. 00625006530- BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH- 61801633. 00625006530- TRILOGY BONE SCR 6.5X30- 61786234. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 - 2021 - 00258 - 1. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO PATIENT EXPERIENCING WORSENING SYMPTOMS AND ELEVATED METAL IONS. DURING THE PROCEDURE VERY DARK COLORED FLUID CONSISTENT WITH CORROSION WAS DISCOVERED. CORROSION WAS NOTED IN THE HEAD/NECK JUNCTION. FEMORAL HEAD WAS REMOVED AS WELL AS LINER. SHELL WAS WELL FIXED AND POSITIONED THEREFORE RETAINED. ABDUCTORS WERE INTACT AND APPEARED TO BE VIABLE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487441 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 61683933

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10.