BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 7CM DIAHPYSEAL SEGMENT

    MDR report key: 7969866 · Received October 16, 2018

    Report

    Report Number
    0001825034-2018-09666
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    September 26, 2018
    Report Date
    April 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: DIAH SEG LOCK SCREW SET ITEM# 150481 LOT# 857090R, OSS 7CM SEGMENTAL FEMORAL RT ITEM# 150354 LOT# 113880, OSS POLY FEMORAL BUSHINGS 2PK ITEM# 150477 LOT# 206420, OSS POLY LOCK PIN ITEM# 150478 LOT# 229020, OSS POLY TIBIAL BUSHING ITEM# 150476 LOT# 238810, OSS TIBIAL POLY BEARING 14MM ITEM# 150411 LOT# 365420, OSS AXLE ITEM# 150480 LOT# 081300, OSS REINFORCED YOKE ITEM# 150493 LOT# 461040. 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 · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS CONFIRMED AS THE SCREW CAN BE SEEN IN THE JOINT SPACE IN PROVIDED PHOTOS. ADDITIONALLY, THE TIBIAL BEARING PICTURED SHOWS SIGNS OF WEAR AND DELAMINATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELEVANT DEVIATIONS/ ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL 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 THE PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE AND WAS SUBSEQUENTLY REVISED DUE TO SCREW LOOSENING AND COMING OUT OF THE IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812261 OSS 7CM DIAHPYSEAL SEGMENT PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 574110

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R