BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOPSHERE SIZE 36 STD WITH MINI TAPER

    MDR report key: 12590084 · Received October 7, 2021

    Report

    Report Number
    0001825034-2021-02800
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    September 22, 2021
    Report Date
    January 20, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT 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). MEDICAL PRODUCT: CATALOG #: XL-115363, ARCOM XL 44-36 STD HMRL BRNG, LOT # 792100; CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 919120; CATALOG #: XL-115365, ARCOM XL 44-36 RTNV+3 HMRL BRG, LOT # 875730; CATALOG #: 115340, COMP RVS HMRL TI TRAY 44MM, LOT # UNKNOWN. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2021-02799.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVERSE SHOULDER REPLACEMENT FOR A DELAYED PROXIMAL HUMERAL FRACTURE USING THE COMPREHENSIVE SYSTEM. AT THE TIME THE OPERATION WENT AS PLANNED. PATIENT CAME BACK TO CLINIC RECENTLY AND HAD DESCRIBED THAT SHE HEARD A CLICK IN HER SHOULDER LIFTING A HEAVY BOX BUT NO PAIN OR CHANGE TO RANGE OF MOVEMENT. PATIENT THEN REPORTED THAT SHE WAS OUT WALKING THE DOG AND THE DOG PULLED ON THE LEASH. SINCE THEN SHE HAS EXPERIENCED MORE PAIN AND DISCOMFORT AT SHOULDER. ON REVIEW AT CLINIC RECENTLY THE X-RAY SHOWED THAT THE SHOULDER WAS OUT OF JOINT AND WOULD REQUIRE REVISION SURGERY. THE PATIENT WAS REVISED OF THE HUMERAL TRAY AND HUMERAL BEARING OF THE COMPREHENSIVE REVERSE (ALL OTHER IMPLANTS WERE LEFT AS PLANNED) APPROXIMATELY A WEEK AGO. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487942 UNKNOWN GLENOPSHERE SIZE 36 STD WITH MINI TAPER PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R