BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER DISTAL FEMORAL STEM

    MDR report key: 6979228 · Received October 26, 2017

    Report

    Report Number
    0001825034-2017-09675
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 29, 2017
    Report Date
    March 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: OSS TIBIAL POLY BEARING 16MM, CATALOG # 150412, LOT # 053600; OSS POLY TIBIAL BUSHING, CATALOG # 150476, LOT # 249050; OSS POLY LOCK PIN, CATALOG # 150478, LOT # 141560; OSS REINFORCED YOKE, CATALOG # 150493, LOT # 157480; OSS RS POLY FEM BUSHINGS SET/2, CATALOG # 161034, LOT # 153220; OSS RS AXLE, CATALOG # 161035, LOT # 035280.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OX X-RAYS REVEALED THAT HARDWARE APPEARS TO BE FRACTURED OR DISLOCATED DISTALLY AND CONFIRMS THE EVENT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN 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 A CUSTOM IMPLANT APPEARED TO HAVE FAILED. THIS FAILURE WAS SHOWN IN THE RADIOGRAPH. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY 7 1/2 YEARS POST INITIAL SHOULDER SURGERY DUE TO FEMUR INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760112 ZIMMER DISTAL FEMORAL STEM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 292240

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| O| R