BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD TRIAL

    MDR report key: 6672619 · Received June 28, 2017

    Report

    Report Number
    0001825034-2017-04376
    Event Type
    Injury
    Date Received
    June 28, 2017
    Report Date
    November 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWT
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL PRODUCT: COMPR NANO HMRL PPS 36MM, CAT#: 115736 LOT#: 648820; VERSA-DIAL/COMP TI STD TAPER, CAT# 118001 LOT#: 764220; VERSA-DIAL 50X21X57 HUM HEAD, CAT#: 113053 LOT#: 833450; MD HYBRID GLENOID BASE 4MM, CAT#: 113954 LOT#: 678430; PT HYBRID GLEN POST REGENEREX, CAT#: PT-113950, LOT# 461240. CUSTOMER HAS INDICATED THAT THE DEVICE IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET (B)(4) 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 BY REVIEW OF X-RAYS PROVIDED. PROVISIONAL HEAD IS RETURNED FOR EVALUATION. DIMENSIONS TAKEN ARE WITHIN SPECIFICATIONS 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. BOTH HEX FEATURES STRIPPED ON THE SCREWS WHILE TRYING TO DISASSEMBLE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. X-RAY REVIEW SHOW FIRST TWO TIME POINTS APPEAR UNREMARKABLE WITHOUT PERIPROSTHETIC LUCENCIES. HOWEVER, ON THE LAST TIME POINT, SLIGHTLY LESS THAN 6 MONTHS FROM ORIGINAL IMAGING, A WELL DEMARCATED PERIPROSTHETIC LUCENCY IS SEEN DISTAL TO THE CENTRAL PORTION OF THE HUMERAL HARDWARE COMPONENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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 APPROXIMATELY SIX (6) WEEKS AND SIX (6) MONTHS POST-OPERATIVELY. HUMERAL OSTEOLYSIS WAS ADDITIONALLY 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
    453872 VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD TRIAL TEMPLATE HWT BIOMET ORTHOPEDICS N/A ZB110901

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other