BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS 60MM DST HUM BDY LT

    MDR report key: 6403997 · Received March 14, 2017

    Report

    Report Number
    0001825034-2017-01558
    Event Type
    Injury
    Date Received
    March 14, 2017
    Date of Event
    February 6, 2017
    Report Date
    November 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PK153398
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - COMPR SRS ANTI ROT IC SEG-30MM, CAT#: 211266, LOT#: 515410; COMPR SRS MOD STEM - 10X100MM, CAT#: 211237, LOT#: 871110; HUMERAL SCREW KIT 2 HUMERAL SCREWS, CAT#: 00840009000, LOT#: 63425387; ARTICULATION KIT SIZE 5/6 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS B, CAT#: 00840009500, LOT#: 63396483; COMPR SRS LARGE FLANGE, CAT#: 211270, LOT#: 231150; ELBOW TORQUE DRIVER, CAT#: 00840108000, LOT#: 56613805; COMPR SRS IC SEG - 60MM, CAT#: 211225, LOT#: 104420. CONCOMITANT MEDICAL PRODUCTS ¿ THERAPY DATE ¿ UNKNOWN DATE IN (B)(6) 2017. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [AS IT REMAINS IMPLANTED AT THE TIME OF THIS REPORT] TO ZIMMER BIOMET FOR INVESTIGATION. 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:1825034-2017-01558 / 01566.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT X RAY¿S WERE EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. AN X-RAY WAS PROVIDED AND REVIEWED. THE RESULTS OF THE REVIEW IDENTIFIED THE FOLLOWING: "COMPREHENSIVE SEGMENTAL DISTAL HUMERAL/ELBOW RECONSTRUCTION PROSTHESES ARE PRESENT. THE HUMERAL DISTAL BODY COMPONENT IS COMPLETELY DISSOCIATED FROM THE HUMERAL STEM COMPONENT, AND IS DISPLACED MEDIALLY. A STABILIZING PLATE AND SCREW ARE NOT IDENTIFIED IN THE VICINITY OF JUNCTION OF HUMERAL STEM AND BODY COMPONENTS." ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 HAS BEEN REPORTED THAT THE PATIENT UNDERWENT A LEFT ELBOW ARTHROPLASTY AND APPROXIMATELY 12 DAYS POST-IMPLANTATION THE PATIENT STATED HEARING A CLICKING SOUND. RADIOGRAPHS REVEAL THAT THE HUMERAL COMPONENT HAS FAILED AND SEPARATED FROM THE INTERCALARY SEGMENT. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185854 COMPR SRS 60MM DST HUM BDY LT PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 115510

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention