BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 16151722 · Received January 12, 2023

    Report

    Report Number
    0001825034-2023-00063
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    December 22, 2022
    Report Date
    January 13, 2023
    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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 150374 - OSS CEMENTED IM STEM 13X225 - 402850. 150419 - OSS NON-MOD TIB PLATE LONG 63 - 443540. 150476 - OSS POLY TIBIAL BUSHING - 459130. 150415 - OSS TIBIAL POLY BEARING 22MM - 093530. 161034 - OSS RS POLY FEM BUSHINGS SET/2 - 365680. 150478 - OSS POLY LOCK PIN - 530340. 161035 - OSS RS AXLE - 163490. 151801 - OSS RS 3CM RESURFACING RT - 905590. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE DEVICE HAS FOREIGN MATERIAL ON IT AND A FIN HAS FRACTURED OFF THE BODY OF THE DEVICE. NO OTHER DEFINITIVE STATEMENTS CAN BE MADE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 MONTHS LATER DUE TO AN IMPLANT FRACTURING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132513 OSS REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 726920 00880304240094

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R