BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL 32MM RLC LNR HW SZ24

    MDR report key: 12543573 · Received September 28, 2021

    Report

    Report Number
    0001825034-2021-02762
    Event Type
    Injury
    Date Received
    September 28, 2021
    Report Date
    December 6, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K042051
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY AND SUBSEQUENTLY 5 YEARS LATER IS EXPERIENCING PAIN, LOSS OF BALANCE, DIZZINESS, ELEVATED METAL IONS, DIFFICULTY IN WALKING AND UPSET STOMACH DUE TO THE DETERIORATION AND FAILURE OF IMPLANT. NO REVISION HAS BEEN REPORTED AT THIS TIME. NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PART: 11-104209, LOT: 831670, MLRY-HD LAT POR FMRL 9X150MM. PART: 163668, LOT: 324300, 32MM MOD HEAD COCR -3MM NECK. PART: 14-103654, LOT: 651160, UNIV 2-HOLE SHL 54MM LNR SZ 24. PART: 103536, LOT: 027150, TI LOW PROFILE SCREW 6.5X45MM. FOREIGN: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02726, 0001825034-2021-02756, 0001825034-2021-02761.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND SUBSEQUENTLY 5 YEARS LATER IS EXPERIENCING PAIN, LOSS OF BALANCE, DIZZINESS, ELEVATED METAL IONS, DIFFICULTY IN WALKING AND UPSET STOMACH DUE TO THE DETERIORATION AND FAILURE OF IMPLANT. NO REVISION HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439890 ARCOMXL 32MM RLC LNR HW SZ24 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 418200

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEE H10