BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS ANTI ROT IC SEG-30MM

    MDR report key: 8390574 · Received March 5, 2019

    Report

    Report Number
    0001825034-2019-00985
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    December 17, 2018
    Report Date
    June 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED: THE COMPLAINT WAS CONFIRMED BASED ON THE OPERATIVE NOTES THAT WAS PROVIDED STATING DRAINING QUITE A BIT FROM OPENING AT THE APEX OF THE INCISION WHERE THE DISTAL HUMERAL COMPONENT IS NEARLY SUBCU. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 REPORTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110029939 COMPR SRS 60MM DST HUM BDY RT 588380; 211269 COMPR SRS SMALL FLANGE 155830; 211236 COMPR SRS MOD STEM - 8X100MM 365290; 00840002411 ULNAR COMPONENT PLASMA SPRAYED SIZE 4 115 MM LENGTH RIGHT FOR CEMENTED USE ONLY 63269429. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DISCARDED. 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 -2019 -00984; 0001825034 -2019 -00987; 0001825034 -2019 -00988.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE BROKEN IMPLANT AND WAS SUBSEQUENTLY REVISED TO REMOVE THE REMAINING HARDWARE DUE TO INFECTION APPROXIMATELY 3 WEEKS POST REVISION SURGERY. DRAINAGE OF THE SURGICAL SITE AND VISIBLE, EXPOSED HARDWARE WAS NOTED THROUGH THE INCISION SITE. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184077 COMPR SRS ANTI ROT IC SEG-30MM PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 351820

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R