BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY ELBOW HUMERAL CONDYLE KIT

    MDR report key: 7252428 · Received February 8, 2018

    Report

    Report Number
    0001825034-2018-00501
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    January 17, 2018
    Report Date
    March 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    PK051975
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 211255 COMPR SRS 70MM DST HML BDY RT 829690, 211263 COMPR SRS MOD STEM - 11X100MM 594160, 211225 COMPR SRS IC SEG - 60MM 428220, 114823 DISC ULNA 4X75MM RT W/BRNG C 243900. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. 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)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR# 0001825034-2018-00500. CONCOMITANT: COMPREHENSIVE SRS/ DISCOVERY DISTAL BODY WITH SCREW PN211255 LN829690. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS IMPLANTED INTO THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUMERAL DISTAL BODY WITH SCREW IMPLANT FAILED TO ENGAGE CORRECTLY AT POINT OF REDUCTION WITH ELBOW SYSTEM HUMERAL CONDYLE KIT. THE SCREW HOLES OF THE HUMERAL BODY AND HUMERAL CONDYLE DID NOT MATCH AFTER THE COMPONENTS HAD BEEN IMPLANTED WITH BONE CEMENT. THE SURGEON COMPLETED THE PROCEDURE AND NOTED THAT THERE IS A HIGH PROBABILITY OF DISLOCATION IN THE FUTURE DUE TO INADEQUATE FIXATION. THERE WAS NO SURGICAL DELAY REPORTED. DISLOCATION HAS SINCE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98547 DISCOVERY ELBOW HUMERAL CONDYLE KIT PROSTHESIS, ELBOW JDC ZIMMER BIOMET, INC. N/A 928080

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention