BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 13653277 · Received March 2, 2022

    Report

    Report Number
    0001825034-2022-00447
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    February 17, 2022
    Report Date
    May 26, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: COMP RVS TRAY CO 44MM CAT: 115370 LOT: UNKNOWN; ARCOM XL 44-36 STD HMRL BRNG 36MM CAT: XL-115363 LOT: 874890; COMP AUG MINI BSPLT W TPR MD CAT: 110032420 LOT: 64298726. REPORT SOURCE: FOREIGN: (B)(6). 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 REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00445, 0001825034-2022-00446, 0001825034-2022-00448 . PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NOT REPORTABLE.- THE RETURNED FRAGMENT DOES NOT MATCH ANY OF THE RETURNED IMPLANTS. THIS EVENT WILL BE REPORTED UNDER MEDWATCH: 0001825034-2022-01296. 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 THAT THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR AND 2 DAYS POST IMPLANTATION DUE TO A FOREIGN OBJECT IDENTIFIED ON POST OP RADIOGRAPHS. THE OBJECT WAS REMOVED AND ALL COMPONENTS 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2294633 COMP RVRS SHLDR GLNSP STD 36MM SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. 502220

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention| H SEE H10