BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL 36MM RLC LNR MROM SZ24

    MDR report key: 11884022 · Received May 26, 2021

    Report

    Report Number
    0001825034-2021-01605
    Event Type
    Injury
    Date Received
    May 26, 2021
    Report Date
    September 20, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K950761
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: CATALOG#: 103534, TI LOW PROFILE SCREW 6.5X35MM IA6.5X35MM, LOT#: 642060. CATALOG#: 13-104156, M/H 3HOLE RLC SHL NRS 56MM/L24, LOT#: 215870. CATALOG#: 103532, BM ACET LP DOME SCW TI S/TAP D IA6.5X25MM, LOT#: 120880. CATALOG#: 135300, ACETABULAR APEX PLUG, LOT#: 033870. CATALOG#: 11-363662, 36MM COCR MOD HD STD, LOT#: 351930. CATALOG#: 51-104110, TPRLC 133 T1 PPS HO 11X142MM 2MM T1, LOT#: 3727019. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED CORRECTED: D4 (CATALOG NUMBER).

    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 WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: CATALOG#: 103534 TI LOW PROFILE SCREW 6.5X35MM IA6.5X35MM LOT#: 624060. CATALOG#: 13-104156 M/H 3HOLE RLC SHL NRS 56MM/L24 LOT#: 215780. CATALOG#: 103532 BM ACET LP DOME SCW TI S/TAP D IA6.5X25MM LOT#: 120880. CATALOG#: 135300 ACETABULAR APEX PLUG LOT#: 033870. CATALOG#: 11-363662 36MM COCR MOD HD STD LOT#: 351930. CATALOG#: 51-104110 TPRLC 133 T1 PPS HO 11X142MM 2MM T1 LOT#: 3727019. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01594, 0001825034-2021-01600, 0001825034-2021-01601, 0001825034-2021-01602, 0001825034-2021-01603, 0001825034-2021-01608.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS EXPERIENCING A FEELING LIKE FIRE IS RUNNING DOWN THE LEG AND HIP, NUMBNESS, PAIN, FEELS LIKE A TENNIS BALL IS IN THE BUTT CHEEK, THE PATIENT CANNOT RIDE IN A VEHICLE FOR LONG PERIODS, AND THE PATIENT HAS DIFFICULTY LIFTING HIS LEG APPROXIMATELY 4 YEARS AND 9 MONTHS POST IMPLANTATION. 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
    783521 ARCOMXL 36MM RLC LNR MROM SZ24 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 464560

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10 NARRATIVE.| SEE H10 NARRATIVE.