BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL TRAY STANDARD - TITANIUM

    MDR report key: 8435977 · Received March 20, 2019

    Report

    Report Number
    0001825034-2019-01298
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 13, 2018
    Report Date
    July 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Removal / Correction Number
    Z-1103-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS AND MEDICAL RECORDS. X-RAY REVEALED FRACTURE OF HUMERAL COMPONENT AT THE MORSE TAPER AT THE JUNCTION BETWEEN HUMERAL STEM AND TRAY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO DESIGN DEFICIENCY. A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE MANUFACTURING DEFICIENCY. 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). CONCOMITANT MEDICAL PRODUCTS: 115330 LOT 791180 COMPREHENSIVE RVRS SHDR GLEN BSPLT +HA, 115381 LOT 689350 COMPREHENSIVE RVRS CNTRL SCR 6.5X25MM ST, 180503 LOT 003040 COMPREHENSIVE LOCKING SCREW 3.75X30MM, 180502 LOT 289800 COMPREHENSIVE LOCKING SCREW 4.75X25MM, 180507 LOT 852480 COMPREHENSIVE NON-LOCKING SCREW 4.75X15MM, 118001 LOT 483010 COMPREHENSIVE VERSA-DIAL/COMP TI STD TAPER, 180507 LOT 852470 COMPREHENSIVE NON-LOCKING SCREW 4.75X15MM, 180507 LOT 268890 COMPREHENSIVE NON-LOCKING SCREW 4.75X15MM, 115310 LOT 432570 COMPREHENSIVE RVRS SHLDR GLNSP STD 36MM, 113628 LOT 140360 COMPREHENSIVE PRIMARY STEM 8MM MINI, XL-115363 LOT 582670 COMPREHENSIVE ARCOM XL 44-36 STD HMRL BRNG. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT WAS REVISED EIGHT YEARS POST-IMPLANTATION DUE TO FRACTURE OF HUMERAL COMPONENT. POLYETHYLENE WEAR CONSISTENT WITH SCAPULAR NOTCHING WAS FOUND. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229532 HUMERAL TRAY STANDARD - TITANIUM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 660000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R