BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD TRIAL

    MDR report key: 6672646 · Received June 28, 2017

    Report

    Report Number
    0001825034-2017-04397
    Event Type
    Injury
    Date Received
    June 28, 2017
    Report Date
    November 7, 2017
    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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. VISUAL OBSERVATION OF THE PROVISIONAL CONFIRMED THAT BOTH SCREW HEADS WERE AT, OR BELOW FLUSH PRIOR TO DISASSEMBLY. ONE OF THE HEX FEATURES STRIPPED ON A SCREW WHILE TRYING TO DISASSEMBLE. DIMENSIONS TAKEN ARE WITHIN SPEC. X-RAY REVIEWER STATED "PERIPROSTHETIC LUCENCIES WAX AND WANE AT DIFFERENT TIME POINTS. INTERESTINGLY INITIAL DETECTION IS 2 DAYS AFTER INITIAL IMAGING AT WHICH NO PERIPROSTHETIC LUCENCY WAS CLEARLY DISCERNABLE (I.E. BETWEEN (B)(6) 2014). ALTHOUGH THE ABNORMAL LUCENCY CONTINUES TO EXTEND LATERALLY THROUGH (B)(6) 2015, THE BONE BEGINS TO MINERALIZE ON (B)(6) 2015 AND THE LUCENCY BEGINS TO BECOME LESS APPARENT. HOWEVER ON THE LAST TIME POINT, AT LEAST ON AP VIEWS, THE LUCENCIES ARE MORE READILY APPARENT." DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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). MEDICAL PRODUCT: COMPR NANO HMRL PPS 38MM, CAT#: 115738 LOT#: 648840, VERSA-DIAL/COMP TI STD TAPER, CAT#: 118001 LOT#: 990230, VERSA-DIAL 50X27X50 HUM HEAD, CAT#: 113057 LOT#: 204260, MD HYBRID GLENOID BASE 4MM, CAT#: 113954 LOT#: 119210, PT HYBRID GLEN POST REGENEREX GENEREX, CAT#: PT-113950 LOT#: 792590. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, HUMERAL COMPONENT RADIOLUCENCY WAS NOTED AT VARYING TIMES SPANNING FROM TWO (2) DAYS TO ONE (1) YEAR POST-OPERATIVELY. SIGNS OF HUMERAL OSTEOLYSIS WERE ALSO 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
    454246 VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD TRIAL TEMPLATE HWT BIOMET ORTHOPEDICS N/A 848310

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other