BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 11716182 · Received April 23, 2021

    Report

    Report Number
    0001825034-2021-01217
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 12, 2019
    Report Date
    June 3, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304240094
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2021-01218 0001825034-2021-01219 0001825034-2021-01220 0001825034-2021-01221 0001825034-2021-01222 0001825034-2021-01223 0001825034-2021-01224 0001825034-2021-01225 0001825034-2021-01226 CONCOMITANT MEDICAL PRODUCTS: OSS TIBIAL POLY BEARING 20MM, ITEM# 150414 LOT# 237060 OSS POLY LOCK PIN, ITEM# 150478 LOT# 348850 OSS NON-MOD TIB PLATE SHORT 67, ITEM# 150417 LOT# 203610 OSS 7CM SEGMENTAL FEMORAL RT, ITEM# 150354 LOT# 756200 OSS POLY TIBIAL BUSHING, ITEM# 150476 LOT# 460720 OSS POLY FEMORAL BUSHINGS, ITEM# 150477 LOT# 370100 OSS AXLE, ITEM# 150480 LOT# 543370 OSS REINFORCED YOKE, ITEM# 150493 LOT# 658130 OSS TIBIAL POLY BEARING 22MM, ITEM# 150415 LOT# 382120 OSS 3CM ELLIP DIAPHYSEAL SEG, ITEM# 150461 LOT# 150610 OSS CEMENTED IM STEM 15MMX90MM, ITEM# 150363 LOT# 810360 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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 A PATIENT WAS REVISED APPROXIMATELY TWO MONTHS¿ POST IMPLANTATION DUE TO WOUND HEALING PROBLEMS THAT DISENGAGED HIS HINGED FEMUR FROM HIS RIGHT TIBIAL COMPONENT. THIS WAS A RESULT OF HAVING HAD A DISTAL FEMORAL REPLACEMENT WITH ABSENCE OF COLLATERAL LIGAMENTS CAUSING THE FEMUR TO DISENGAGE FROM THE TIBIA WHEN THE KNEE BECAME FLEXED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615723 OSS REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 211420 00880304240094

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R