BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 7207693 · Received January 19, 2018

    Report

    Report Number
    0001825034-2018-00274
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    March 4, 2017
    Report Date
    January 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 150476; OSS POLY TIBIAL BUSHING, LOT # 510910, ITEM # 150477; OSS POLY FEMORAL BUSHINGS 2PK, LOT # 780760, ITEM # 150478; OSS POLY LOCK PIN; LOT #576750, ITEM # 150412; OSS TIBIAL POLY BEARING; LOT # 231210, ITEM # 150480; OSS AXLE; LOT # 274490, ITEM # 150355; OSS SEGMENTAL FEMORAL LT; LOT # 919810, ITEM # 150481; DIAH SEG LOCK SCREW SET; LOT # 935180, ITEM # 150419; OSS NON-MOD TIB PLATE LONG; LOT # 612080, ITEM # 150426; OSS TIB BLK AUG UNIV; LOT # 015450, ITEM # 150426; OSS TIB BLK AUG UNIV; LOT # 896800, ITEM # 150461; OSS ELLIP DIAPHYSEAL SEG; LOT # 755520, ITEM # 150368; OSS CEMENTED IM STEM ; LOT # 691040. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    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
    50690 OSS REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 066340

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R