BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 7333512 · Received March 13, 2018

    Report

    Report Number
    0001825034-2018-01833
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    March 19, 2018
    Report Date
    December 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). MEDICAL PRODUCTS OSS MOD TIB BASEPLATE 71MM, ITEM# 150422, LOT# 320600; OSS SMOOTH STM W/SRW 150BW-11, ITEM# CP111652, LOT# 476760; OSS RS AXLE, ITEM# 161035, LOT# 274500; OSS RS POLY FEM BUSHINGS SET/2, ITEM# 161034, LOT# 660310; OSS POLY TIBIAL BUSHING, ITEM# 150476, LOT# 132820; OSS POLY LOCK PIN, ITEM# 150478, LOT# 610360; OSS TIBIAL POLY BEARING 12MM, ITEM# 150410, LOT# 078480. OSS RS 5 CM RESURF FMRL-RT, ITEM# 161007, LOT# 581410. INTRAMEDULLARY PLUG LGE, ITEM# 130613, LOT# 181620. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO ANOMALIES / DEVIATIONS 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE. THE EARS OF THE YOKE HAD FRACTURED. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT KNEE ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, THE SURGEON IS REQUESTING DEVICE FOR A REVISION SURGERY DUE TO IMPLANT FRACTURE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178451 OSS REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 815910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention