BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X45MM ST/RST

    MDR report key: 7247062 · Received February 7, 2018

    Report

    Report Number
    0001825034-2018-00743
    Event Type
    Injury
    Date Received
    February 7, 2018
    Date of Event
    December 21, 2017
    Report Date
    March 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAY REVIEWER STATED THERE WAS SOME ANGULATION OF THE GLENOID COMPONENT WITH RESPECT TO THE GLENOID WITH SPACING INBETWEEN THE GLENOID FIXATION DEVICE AND THE BONY GLENOID SUPERIORLY AND POSTERIORLY WHICH COULD CONTRIBUTE TO LOOSENING. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THE ROOT CAUSE WAS DETERMINED TO BE RELATED TO USE ERROR. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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: 118001, VERSA-DIAL/COMP TI STD TAPER, 005800. THE 115330, COMP RVRS SHDR GLEN BSPLT +HA, 652700. THE 113633, COMP PRIMARY STEM 13 MM MINI, 519330. THE 115310, COMP RVRS SHLDR GLNSP STD 36 MM, 063160. XL-115363, ARCOM XL 44-36 STD HMRL BRNG, 864490. THE 115370, COMP RVS TRAY CO 44 MM, 901970. THE 180552, COMP LK SCR 3.5HEX 4.75X25 ST, 938320. THE 180551, COMP LK SCR 3.5HEX 4.75X20 ST, 165790. THE 180552, COMP LK SCR 3.5HEX 4.75X25 ST, 096560. THE 180551, COMP LK SCR 3.5HEX 4.75X20 ST, 890110. CUSTOMER HAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN, DISASSOCIATION, AND LIMITED RANGE OF MOTION. THE GLENOSPHERE COMPONENT SPUN BECAUSE THE CENTRAL SCREW HAD NOT BEEN SEATED FULLY. THE GLENOSPHERE AND HUMERAL TRAY WERE REVISED WITH THE POLY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93161 COMP RVS CNTRL 6.5X45MM ST/RST SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. N/A 853360

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R