BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 6811822 · Received August 22, 2017

    Report

    Report Number
    0001825034-2017-06564
    Event Type
    Injury
    Date Received
    August 22, 2017
    Date of Event
    April 5, 2013
    Report Date
    December 13, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE ADDITIONAL COMPONENTS: COMP RVRS 25MM BSPLT HA+ADPTR CATALOG#: 010000589 LOT: 487060; COMP 8MM HUM FRAC STEM MACRO CATALOG# 11-113558 LOT: 603290; COMP RVS CNTRL SCR 6.5X35MM ST CATALOG# 115383 LOT: 075890; INTRAMEDULLARY PLUG SM 8-10MM CATALOG#: 130609 LOT: 318940; COMP LOCKING SCREW 4.75X15MM CATALOG#: 180500 LOT: 184000; COMP LOCKING SCREW 4.75X20MM CATALOG#: 180501 LOT: 746070; COMP. REV SHLDR 9 IN STEINMANN CATALOG: 405800 LOT: 054050; COMP RVS 2.7MM DIA DRL CATALOG#: 405889 LOT: 964010; COMP LOCKING SCREW 4.75X15MM CATALOG#: 180500 LOT: 773420. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP RVRS SHLDR GLNSP STD 36MM PART # 115310 LOT # 802190, COMP RVS TRAY CO 44MM PART # 115370, LOT # 728600. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 06562, 0001825034 - 2017 - 06563. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER PROSTHESIS PROCEDURE. BUT AFTER THE SURGERY THE PATIENT WAS UNABLE TO LIFT HER RIGHT ARM WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590641 ARCOM XL 44-36 STD HMRL BRNG PROTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 686780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R