BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMP TI STD TAPER

    MDR report key: 8929937 · Received August 26, 2019

    Report

    Report Number
    0001825034-2019-03778
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    September 5, 2018
    Report Date
    January 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4 (EXPIRATION DATE), G4, G7, H1, H2, H3, H4, H6, H10. CORRECTED: D1, D2, D4 (CATALOG AND LOT#), D6, D11, G5. D11: 115330 COMP RVRS SHDR GLEN BSPLT +HA 791180 115310 COMP RVRS SHLDR GLNSP STD 36MM 432570 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 00356 REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS AND MEDICAL RECORDS. REVIEW OF THE AVAILABLE MEDICAL RECORDS/RADIOGRAPHS IDENTIFIED THE FOLLOWING: 05-SEP-2018: X-RAYS TAKEN NOTE LEFT (L) SIDE WITH SCAPULAR NOTCHING JUST BELOW THE INFERIOR SCREW OF THE L SHOULDER; HOWEVER, ALIGNMENT IS SATISFACTORY. NO EVIDENCE OF SUBLUXATION OR DISLOCATION. THE PATIENT NOTED OVERALL SATISFIED WITH OUTCOME. 27-MAR-2019: X-RAYS TAKEN ON L SIDE NOTES INFERIOR SCAPULAR NOTCHING INTO THE LATERAL PILLAR OF THE L SHOULDER; HOWEVER, ALIGNMENT IS SATISFACTORY. DEVICE HISTORY RECORD (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 EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115370, COMP RVS TRAY CO 44MM,UNKNOWN, 113647, COMP PRIMARY STEM 7MM STD, 939230, EB0101, TORNIER RESTRICTOR CEMENT, UNKNOWN , 6197-9-010, STRYKER CEMENT SIMPLEX P, MKY067, 6197-9-010, STRYKER CEMENT SIMPLEX P, MJY056. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03777 . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [ REMAINS IMPLANTED ]. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S LEFT SHOULDER WAS FOUND TO HAVE INFERIOR SCAPULAR NOTCHING INTO THE LATERAL PILLAR APPROXIMATELY 6 MONTHS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726553 VERSA-DIAL/COMP TI STD TAPER PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 483010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10| SEE NARRATIVE IN H10