BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 22MM

    MDR report key: 11716344 · Received April 23, 2021

    Report

    Report Number
    0001825034-2021-01226
    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
    JDI
    UDI-DI
    00880304006508
    PMA / PMN Number
    K002757
    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

    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: 0001825034-2021-01217. 0001825034-2021-01218. 0001825034-2021-01219. 0001825034-2021-01220. 0001825034-2021-01221. 0001825034-2021-01222. 0001825034-2021-01223. 0001825034-2021-01224. 0001825034-2021-01225. MEDICAL PRODUCT: OSS REINFORCED YOKE, ITEM# 150493, LOT# 211420. 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 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
    615195 OSS TIBIAL POLY BEARING 22MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 382120 00880304006508

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R