BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 14880224 · Received June 30, 2022

    Report

    Report Number
    0001825034-2022-01548
    Event Type
    Injury
    Date Received
    June 30, 2022
    Report Date
    August 17, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K120121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP RVRS SHLDR GLNSP STD 36MM CAT: 115310 LOT: 434100, COMP RVS TRAY CO 44MM CAT: 115370 LOT: 705830, COMP RVRS 25MM BSPLT HA+ADPTR CAT: 010000589 LOT: 017520, COMP NLK SCR 3.5HEX 4.75X20 ST CAT: 180558 LOT: 480980, COMP PRIMARY STEM 12MM MINI CAT: 113632 LOT: 391930, COMP RVS CNTRL SCR 6.5X25MM ST CAT: 115381 LOT: 596340, COMP LOCKING SCREW 4.75X25MM CAT: 180502 LOT: 886840, COMP LK SCR 3.5HEX 4.75X30 ST CAT: 180553 LOT: 285180, COMP NLK SCR 3.5HEX 4.75X15 ST CAT: 180557 LOT: 770300. REPORT SOURCE: FOREIGN: (B)(6). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SENTINEL EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO UNKNOWN REASONS. THE HUMERAL BEARING, GLENOSPHERE, CENTRAL SCREW, PERIPHERAL SCREW, AND HUMERAL TRAY WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SENTINEL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206902 ARCOM XL 44-36 STD HMRL BRNG SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. 937340

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H