BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL BEARING

    MDR report key: 7757151 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-04676
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    March 19, 2013
    Report Date
    September 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115330, COMP RVRS SHDR GLEN BSPLT +HA, 283220; 180501, COMP LOCKING SCREW 4.75X20MM, 048230; 113654, COMP PRIMARY STEM 14MM STD, 953080; 115380, COMP RVS CNTRL SCR 6.5X20MM, ST 042060; 115310, COMP RVRS SHLDR GLNSP STD 36MM, 355680; 180502, COMP LOCKING SCREW 4.75X25MM, 552500; 118001, VERSA-DIAL/COMP TI STD TAPER, 222080; 115345, COMP RVS HMRL TI TRAY+5MM, 44MM 068890. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. 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 -2018 -04675.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO INSTABILITY APPROXIMATELY ONE YEAR, SIX MONTHS POST REVISION SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599649 COMPREHENSIVE REVERSE HUMERAL BEARING PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 205480

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R