BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM TITANIUM OSS RS MAK 7CM SEGMENTAL FEMORAL ROTATING HINGE KNEE

    MDR report key: 7562465 · Received June 1, 2018

    Report

    Report Number
    0001825034-2018-03708
    Event Type
    Injury
    Date Received
    June 1, 2018
    Report Date
    January 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PCUSTOM
    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

    (B)(4). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND 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. OSS 3CM ELLIP DIAPHYSEAL SEG, CATALOG# 150461, LOT # 859110.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. THE CUSTOM DEVICE ON THIS COMPLAINT IS SPECIFICALLY DESIGNED TO BE COMPATIBLE WITH ITS MATING STANDARD-LINE AND CUSTOM DEVICES. NO MEDICAL RECORDS RECEIVED. ROOT CAUSE COULD NOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 PATIENT MAY REQUIRE A REVISION PROCEDURE DUE TO EXTRA EXTERNAL ROTATION IS NEEDED FOR APPROPRIATE KINEMATICS. NO REVISION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404874 CUSTOM TITANIUM OSS RS MAK 7CM SEGMENTAL FEMORAL ROTATING HINGE KNEE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 073840

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CUS TI 63AVL 160X10TIB POR10AG| CUS TI OSS AVL YOKE KIT| CUS TI OSS RS LOCK AXLE KIT| MAK OSS BUMPER PLUS| MAK OSS SIDE LOCK STEM SCREW| OSS 3CM ELLIP DIAPHYSEAL SEG| OSS CEMENTED IM STEM 14X150| OSS TIB POLY BEARING 16