BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 16894381 · Received May 9, 2023

    Report

    Report Number
    0001825034-2023-00991
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    April 20, 2023
    Report Date
    October 27, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: 150412 - OSS TIBIAL POLY BEARING 16MM - 775770R. PMI01195 - 67MM TIBIAL COMPONENT - UNKNOWN. PMI01193 - CUSTOM FINNED FEMORAL COMPONENT - UNKNOWN. UNKNOWN - UNKNOWN POLY - UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 150412 - OSS TIBIAL POLY BEARING 16MM - 775770R. CP114584 - CUST THIN FINN TIB BUSHING - 443500. 161035 - OSS RS AXLE - 139240. 150478 - OSS POLY LOCK PIN - 121340. PM100884 - SMALL FMRL BSHG SET - 442970. 402439 - COBALT MV BONE CEMENT 40GM B - 949020. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00992, 0001825034-2023-00994.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 0001825034-2023-01563-1 D10: 150412 - OSS TIBIAL POLY BEARING 16MM - 775770. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVISION OPERATIVE NOTES CONFIRM THAT PATIENT WAS REVISED DUE TO DISLOCATION. ROOT CAUSE CANNOT BE DETERMINED FOR THE DISLOCATION. HOWEVER, THE INCOMPATIBLE COMBINATION OF DEVICES CAN BE ATTRIBUTED TO OFF LABEL USAGE. PER THE SURGICAL TECHNIQUE, UNDER WARNINGS IT STATES THAT 'IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS, OR ABSENCE OF, OR NONFUNCTIONING QUADRICEPS MECHANISM MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS'. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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 FURTHER REPORTED THAT THE PATIENT HAS A SURGICAL HISTORY OF TIBIAL TUMOR RESECTIONS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND HAS UNDERGONE MULTIPLE REVISIONS. SIX MONTHS AFTER THE MOST RECENT REVISION, THE PATIENT UNDERWENT A REVISION OF THE AXLE, YOKE, POLY, AND LOCKING PIN DUE TO DISLOCATION. THE TIBIAL BUSHING WAS NOT REVISED AS THIS WAS A CUSTOM DEVICE AND THERE WAS NO BACKUP AVAILABLE. THERE WAS NO WEAR PRESENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER 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
    581994 OSS REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 273020

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H