BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 44-36 STD HMRL BRNG

    MDR report key: 6995673 · Received November 2, 2017

    Report

    Report Number
    0001825034-2017-09822
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    April 28, 2014
    Report Date
    January 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK113121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115310, COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STD 36MM, 283600, 405883, COMP RVS 3.2MM DRL, 480160, 405889, COMP RVS 2.7MM DIA DRL, 518200, 406669, STN PN THD TIP .125X2.5IN 2PK, 423850, 110003484, ACCESS 3.2MM THD STEINMANN 9, 182340, 113637, COMP PRIMARY STEM 17MM MINI, 781530, 405800, COMP. REV SHLDR 9 IN STEINMANN, 326810, 115330, COMP RVRS SHDR GLEN BSPLT +HA, 827490, 115382, COMP RVS CNTRL SCR 6.5X30MM ST, 203870, 180501, COMP LOCKING SCREW 4.75X20MM, 172390, 180502, COMP LOCKING SCREW 4.75X25MM, 828450, 180501, COMP LOCKING SCREW 4.75X20MM, 465180, 180501, COMP LOCKING SCREW 4.75X20MM, 027490, 118001, VERSA-DIAL/COMP TI STD TAPER, 689660, 115370, COMP RVS TRAY CO 44MM, 477950. CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 09821.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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). THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS FURTHER REPORTED THE PATIENT WAS NON-COMPLIANT WITH POST-OP IMMOBILIZER PROCEDURES. THE PATIENT WENT TO THERAPY, BUT PATIENT DESCRIBED THE THERAPIST PUSHING INTO ABDUCTION EXTERNAL ROTATION AGGRESSIVELY LESS THAN 3 WEEKS AFTER THE SURGERY. PATIENT LIVES IN A RURAL AREA AND THERAPIST WAS INEXPERIENCED IN THIS PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776275 E1 44-36 STD HMRL BRNG PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 378670

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R