BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OSS FEMUR

    MDR report key: 6911188 · Received October 3, 2017

    Report

    Report Number
    0001825034-2017-07649
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    June 22, 2017
    Report Date
    December 6, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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)(4). MEDICAL PRODUCTS - CPS SHORT ANCHOR PLUG # 178554 LOT# 001020, CPS NUT CO-CR-MO ALLOY # 178512 LOT # 285140, CPS CENTERING SLEEVE # 178545 LOT# 694150, OSS POLY TIBIAL BUSHING # 150476 LOT# 464690, OSS POLY LOCK PIN # 150478 LOT# 503140, OSS POLY FEMORAL BUSHINGS # 150477 LOT# 435070, CPS TRANSVERSE PIN # 178530 LOT# 915110, OSS AXLE # 150480 LOT# 150480, OSS REINFORCED YOKE # 150493 LOT# 856000, CPS/OSS TPR ADAPT W/OSS SC # 178711 LOT# 713740, OSS DIAPHYSEAL SEGMENT # 150471 LOT# 630000 AND OSS TIBIAL POLY BEARING # 150411 LOT# 596900. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION OF THE DISTAL FEMUR DUE TO THE CEMENTED FEMORAL STEM LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690435 UNKNOWN OSS FEMUR PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R