BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSS ELLIPTICAL DIAPHYSEAL SEGMENT SCREWS

    MDR report key: 7139482 · Received December 21, 2017

    Report

    Report Number
    0001825034-2017-11400
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    March 4, 2017
    Report Date
    January 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: 150481 DIAH SEG LOCK SCREW SET LOT 935180, 150419 OSS NON-MOD TIB PLATE LONG 63 LOT # 612080, 150426 OSS TIB BLK AUG 10X63/67 UNIV LOT # 896800 150368 OSS CEMENTED IM STEM 14X150 LOT # 691040, 150476 OSS POLY TIBIAL BUSHING LOT # 510910, 150477 OSS POLY FEMORAL BUSHINGS 2PK LOT # 780760, 150478 OSS POLY LOCK PIN LOT # 576750, 150412 OSS TIBIAL POLY BEARING 16MM LOT # 231210, 150480 OSS AXLE LOT # 274490, 150493 OSS REINFORCED YOKE LOT # 066340. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. FROM THE REVISION OP- DURING THE SURGERY, IT WAS NOTED THAT AN ATTEMPT WAS MADE TO REMOVE THE DISTAL SCREW FROM FEMORAL COMPONENT BUT IT APPEARED TO BE COLD WELDED AND APPARENTLY WAS ABANDONED. 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 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)(6). CONCOMITANT MEDICAL PRODUCTS: OSS SEGMENTAL FEMORAL CAT#:150355, LOT#:919810. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 11399, 0001825034 - 2017 - 11400. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REVISION PROCEDURE, AN ATTEMPT WAS MADE TO REMOVE THE DISTAL SCREW FROM FEMORAL COMPONENT BUT IT APPEARED TO BE COLD WELDED AND WAS ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918282 OSS ELLIPTICAL DIAPHYSEAL SEGMENT SCREWS PROSTHESIS, HIP KRO ZIMMER BIOMET, INC. N/A 755520

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR