BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD TRIAL

    MDR report key: 6672643 · Received June 28, 2017

    Report

    Report Number
    0001825034-2017-04398
    Event Type
    Injury
    Date Received
    June 28, 2017
    Report Date
    January 15, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWT
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: COMPR NANO HMRL PPS 32MM, CAT#: 115732 LOT#: 100260, VERSA-DIAL/COMP TI STD TAPER, CAT#: 118001 LOT#: 984300, VERSA-DIAL 46X24X47 HUM HEAD, CAT#: 113046 LOT#: 135050, SM HYBRID GLENOID BASE 4MM, CAT#: 113952 LOT#: 627200, PT HYBRID GLEN POST REGENEREX, CAT#: PT-113950 LOT#: 630080. CUSTOMER HAS INDICATED THAT THE DEVICE IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET WARSAW FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BASED ON THE X-RAY REVIEW. DIMENSIONS TAKEN ARE WITHIN SPEC AS DOCUMENTED ON THE ATTACHED PRINTS AND GAGE DATA SHEET. VISUAL OBSERVATION CONFIRMED THAT BOTH SCREW HEADS WERE AT, OR BELOW FLUSH PRIOR TO DISASSEMBLY. X-RAY REVIEWER STATED "THE RADIOLUCENT ZONES AROUND THE HARDWARE ARE LIKELY RELATED TO THE NATIVE MINERALIZATION OR POSTOPERATIVE CHANGES IN THE HUMERUS. THE LUCENT ZONE MEASURES APPROXIMATELY 2.5 MM ON ALL TIME POINTS". DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, HUMERAL COMPONENT RADIOLUCENCY WAS NOTED AT FOUR (4) DIFFERENT FOLLOW-UP TIMES SPANNING FROM FOUR (4) MONTHS TO ONE (1) YEAR POST-OPERATIVELY, HOWEVER NO PROGRESSION OF THE RADIOLUCENCY HAS BEEN NOTED. THE INITIAL SURGEON NOTED THERE WAS A GAP PRESENT BETWEEN THE HUMERAL COMPONENT AND HUMERAL HEAD IMPLANT DURING THE INITIAL PROCEDURE, DUE TO AN ISSUE WITH A DISCREPANCY BETWEEN THE TRIAL HEAD REPRESENTATION AND THE DEFINITIVE HUMERAL HEAD IMPLANT. THE SURGEON STATES THIS MAY BE LEADING TO THE RADIOLUCENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454249 VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD TRIAL TEMPLATE HWT BIOMET ORTHOPEDICS N/A 176000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other