BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS/OSS 5CM TPR ADAPT W/OSS SC

    MDR report key: 14574984 · Received June 2, 2022

    Report

    Report Number
    0001825034-2022-01282
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 6, 2022
    Report Date
    September 7, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304430792
    PMA / PMN Number
    K043547
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL DEVICE: 151844 - OSS 17CM TAPERED DIAPH SEGMENT - 473410. REPORT SOURCE FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. 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: 0001825034-2022-01283.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. NO OPERATIVE RECORDS WERE PROVIDED. X-RAY PROVIDED WERE REVIEWED BY THIRD HCP AND STATE THAT THERE IS ABNORMAL ANGULATION OF THE PROXIMAL ASPECT OF THE IMPLANT APEX LATERAL CONSISTENT WITH DISASSEMBLY OF THE TAPER RING AS DESCRIBED. 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 A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE WHERE THEY IMPLANTED AN IMPLANT WITHOUT THE SCREW. POSTOPERATIVE X-RAYS TAKEN APPROXIMATELY 6 WEEKS LATER SHOWED THAT THE IMPLANTS HAD DISASSEMBLED AND THE PATIENT UNDERWENT A REVISION PROCEDURE. 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
    197812 CPS/OSS 5CM TPR ADAPT W/OSS SC PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 932560 00880304430792

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R