BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X18X53 HUM HEAD

    MDR report key: 8237091 · Received January 10, 2019

    Report

    Report Number
    0001825034-2018-11402
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 3, 2018
    Report Date
    April 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K040610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED FROM REVIEW OF OPERATIVE NOTES. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH DEVICE SPECIFICATIONS. DHR WAS REVIEWED AND NO DISCREPANCIES 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 11401, 0001825034 - 2018 - 11402, 0001825034 - 2018 - 11403, 0001825034 - 2018 - 11404. (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115740 COMPR NANO HMRL PPS 40MM LOT 820550, 118001 VERSA-DIAL/COMP TI STD TAPER LOT 260450, 113042 VERSA-DIAL 46X18X53 HUM HEAD LOT 060280, 113954 MD HYBRID GLENOID BASE 4MM LOT 268280, PT-113950 PT HYBRID GLEN POST REGENEREX LOT 742260. FOREIGN- THE EVENT OCCURRED IN (B)(6). AS THE DEVICES REMAIN IMPLANTED; THEY WILL NOT BE RETURNED FOR EVALUATION. 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 WAS REPORTED THE PATIENT HAD A SUTURE ABSCESS THAT REQUIRED AN IRRIGATION AND DEBRIDEMENT AS WELL AS ORAL ANTIBIOTICS; PROCEDURE RELATED BUT NOT DEVICE RELATED, APPROXIMATELY SIX (6) WEEKS POST-OPERATIVELY OF A TOTAL SHOULDER ARTHROPLASTY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30063 VERSA-DIAL 46X18X53 HUM HEAD PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A 060280

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R