BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SRS/ DISCOVERY DISTAL BODY WITH SCREW

    MDR report key: 7252425 · Received February 8, 2018

    Report

    Report Number
    0001825034-2018-00500
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    January 17, 2018
    Report Date
    March 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    PK111746
    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: 114700 DISC CONDYLE KIT W/ HEXALOBULA 928080, 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# 0001825034-2018-00501. CONCOMITANT: DISCOVERY ELBOW HUMERAL CONDYLE KIT PN114700 LN928080. (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

    THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT WAS NOT RETURNED; HOWEVER, THROUGH PREVIOUS INVESTIGATION THE DEVICE WAS DETERMINED TO BE NONCONFORMING. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    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
    98544 COMPREHENSIVE SRS/ DISCOVERY DISTAL BODY WITH SCREW PROSTHESIS, SHOULDER JDC ZIMMER BIOMET, INC. N/A 829690

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention