BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HYBRID GLENOID POST¿REGENEREX

    MDR report key: 7960867 · Received October 12, 2018

    Report

    Report Number
    0001825034-2018-09679
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    May 18, 2016
    Report Date
    December 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED. THE COMPLAINT IS CONFIRMED BASED ON THE X-RAYS THAT WERE PROVIDED. X-RAY REVIEW SHOWS, THERE WAS GRADE 2 RADIOLUCENCY OF THE GLENOID COMPONENT IN Z1 AND GRADE 1 RADIOLUCENCY IN Z2, 4, 5, 6, AND 8 AS WELL AS THE CENTRAL PEG. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWS NO DEVIATIONS OR ANOMALIES. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US-115736,COMPREHENSIVE NANO HUMERAL COMPONENT PPS,162430; 118001,COMPREHENSIVE STANDARD TAPER ADAPTOR,871260; 113032,VERSA-DIAL HUMERAL HEAD,314710; 113956,MODULAR HYBRID GLENOID BASE,270010. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09683. PATIENT NOT REVISED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT HAD INITIAL COMPREHENSIVE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, RADIOLUCENCY WAS OBSERVED IN GLENOID ZONE 1 AT 2 YEARS VISIT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800620 MODULAR HYBRID GLENOID POST¿REGENEREX PROTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 431740

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R