BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOMXL RLC 10DEG 36MM SZ25

    MDR report key: 10749920 · Received October 28, 2020

    Report

    Report Number
    0001825034-2020-03900
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 7, 2020
    Report Date
    January 20, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K042051
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE RETURNED DEVICE HAS MARKS ON THE OUTSIDE RADIUS. A 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER 12-115123 ITEM NAME CER BIOLOXD MOD HD 36MM +6 NK LOT # 414000. ITEM NUMBER 192115 ITEM NAME ECHO POR FMRL LAT NC 15X155MM LOT # 565070. ITEM NUMBER 103535 ITEM NAME TI LOW PROFILE SCREW 6.5X40MM LOT # 502030. ITEM NUMBER 31-323230 3.2MMX30MM RNGLC+ ACET DRL BIT 492750. ITEM NUMBER XL-105915 ITEM NAME ARCOMXL 36MM RLC LNR HW SZ25 LOT # 851840. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2020 - 03909.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL RIGHT HIP ARTHROPLASTY, WHEN CHECKING FOR STABILITY THE LINER POPPED OUT OF THE CUP. SURGEON TRIED IMPACTING THE LINER IN AGAIN WITH NO SUCCESS. ALSO CHECKED THE LOCKING RING AND IT WAS FINE. THE SURGEON REMOVED MORE BONE AROUND THE RIM OF THE CUP THINKING THAT'S WHAT WAS INTERFERING WITH THE LINER FULLY SEATING. HE WAS NEVER ABLE TO GET THE LINER TO SEAT INTO THE CUP AND FINALLY USED A DIFFERENT LINER. UPON IMPACTING THE NEW LINER IT WENT IN WITHOUT ISSUE ON THE FIRST TRY. IT WAS NOTED THIS CAUSED A ONE HOUR DELAY. 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
    1217330 ARCOMXL RLC 10DEG 36MM SZ25 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 828370

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR