BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM - POLY TIBIAL BUSHING

    MDR report key: 6451372 · Received March 31, 2017

    Report

    Report Number
    0001825034-2017-02327
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 4, 2017
    Report Date
    January 5, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    Z-1858/1863-2017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO CAUSE OF THE INFECTION IS ATTRIBUTED TO BOTH THE MANUFACTURING AND QUALITY SYSTEM ISSUE AND THE REUSE OF THE FEMORAL IMPLANT. 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: 1825034-2017-02328, 1825034-2017-02329, 1825034-2017-02330.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS REINFORCED YOKE CATALOG 150493 LOT 066340; OSS DIAPHYSEAL SEGMENTAL LOCK SCREW CATALOG 150481 LOT 935180; OSS TIBIAL PLATE CATALOG 150419 LOT 612080; OSS TIBIAL AUGMENT CATALOG 150426 LOT 896800; OSS TIBIAL AUGMENT CATALOG 150426 LOT 015450; OSS SEGMENTAL FEMUR CATALOG 150355 LOT 919810; OSS IM STEM 14X150 CATALOG 150368 LOT 691040; OSS 3CM DIAPHYSEAL SEGMENTAL CATALOG 150368 LOT 691040. CUSTOMER HAS NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-02328, 1825034-2017-02329, 1825034-2017-02330.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND EFFUSION AFTER A KNEE REVISION PROCEDURE, SUBSEQUENTLY, THE PATIENT TESTED POSITIVE FOR (B)(6) AND WAS REVISED APPROXIMATELY TWO MONTHS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231116 ONCOLOGY SALVAGE SYSTEM - POLY TIBIAL BUSHING PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 510910

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R