BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL 32MM RLC LNR +5MM SZ22

    MDR report key: 9145114 · Received October 2, 2019

    Report

    Report Number
    0001825034-2019-04394
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    December 31, 2019
    Report Date
    February 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K042051
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED A DISLOCATION AND UNDERWENT A CLOSED REDUCTION APPROXIMATELY 7 MONTHS POST IMPLANTATION. PATIENT EXPERIENCED ANOTHER DISLOCATION APPROXIMATELY 4 MONTHS LATER. IT IS UNKNOWN IF THERE WAS MEDICAL INTERVENTION AFTER THE SECOND DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION APPROXIMATELY 13 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:105422 LOT NUMBER:227900 BRAND NAME: RNGLC LOCKING RING SZ 22, CATALOG NUMBER: 650-1056 LOT NUMBER:2898752 BRAND NAME: CER BIOLOXD OPTION HD, CATALOG NUMBER:650-1064 LOT NUMBER:2914160 BRAND NAME:CER OPTION TYPE 1 TPR, CATALOG NUMBER:00625006550 LOT NUMBER:64143387 BRAND NAME:BONE SCR 6.5X50 SELF-TAP, CATALOG NUMBER:11-106048 LOT NUMBER:174800 BRAND NAME: R/B RLOC LHOLE SHL 48MM, CATALOG NUMBERX180307: LOT NUMBER:773480 BRAND NAME:BI-METRIC/X POR NC 7X115. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY WITHOUT ANY COMPLICATIONS. THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO METALLOSIS. THE LINER AND HEAD WERE REVISED. THE PATIENT DISLOCATED HER RIGHT HIP AND UNDERWENT A CLOSED REDUCTION ON THE SAME DAY WITHOUT COMPLICATIONS. X-RAY REPORTS CONFIRMED THE DISLOCATION OF THE RIGHT HIP. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISLOCATION AND UNDERWENT A CLOSED REDUCTION APPROXIMATELY 7 MONTHS POST IMPLANTATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938092 ARCOMXL 32MM RLC LNR +5MM SZ22 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 122160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O