BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SEGMENTAL REVISION SYSTEM DISTAL BODY WITH SCREW-RIGHT 70MM

    MDR report key: 6145731 · Received December 5, 2016

    Report

    Report Number
    0001825034-2016-05032
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 8, 2016
    Report Date
    April 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. REVIEW OF DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS OR ANOMALIES. THE INSTRUCTIONS FOR USE INDICATE THE DEVICES USED ARE COMPATIBLE. COMPLAINT HISTORY SEARCH FOUND NO ADDITIONAL COMPLAINT FOR THIS DEVICE. 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.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4). MEDICAL PRODUCT - DISC CONDYLE KIT W/ HEXALOBULA, CATALOG#: 114700 LOT 721800; COMPR SRS MOD STEM - 8X100MM, CATALOG#: 211236 LOT 263930; COMPR SRS SMALL FLANGE, CATALOG#: 211269 LOT 652190; DISC ULNA 3X115MM RT W/BRNG C, CATALOG#: 114817 LOT NI. THERAPY DATE - (B)(6) 2016.

    Description of Event or Problem · 1

    DURING AN ELBOW REVISION OF COMPETITOR PRODUCT, THE DISTAL HUMERUS COMPONENT WOULD NOT FIT WITH THE CONDYLE KIT. A HIGH SPEED BURR WAS UTILIZED TO REMOVE METAL FROM THE COMPONENT TO FACILITATE ASSEMBLY. THE MEDIAL CONDYLE SCREW ALSO REMAINED PROUD AND WAS TIGHT. THIS EVENT CAUSED A 75 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796430 COMPREHENSIVE SEGMENTAL REVISION SYSTEM DISTAL BODY WITH SCREW-RIGHT 70MM PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A 688560

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention SEE NARRATIVE IN H10