BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS XS SHT SPDL W PINS 800LBF

    MDR report key: 8974738 · Received September 9, 2019

    Report

    Report Number
    0001825034-2019-03992
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    April 11, 2019
    Report Date
    February 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101475
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4 (UDI) : (B)(4). D11: ASSOCIATED PRODUCTS : ITEM#: 178562; CPS SHORT ANCHOR PLUG 20MM; LOT# 608710. ITEM#: 178544; CPS CENTERING SLEEVE 22MM; LOT# 903010. ITEM#: 178526; CPS TRANSVERSE PIN 6PK 28MM; LOT# 965300 . MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00479, 0001825034-2020-00480, AND 0001825034-2020-00481.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS, WHICH IDENTIFIED PATIENT HAS AUDIBLE CLICKING AND RADIOGRAPHS SHOW ANCHOR PLUG HAS COLLAPSED WITH LOOSENING OF HARDWARE. DURING THE REVISION PROCEDURE THE IMPLANT WAS NOTED TO BE FRANKLY LOOSE AT ITS BONE INTERFACE AS IT HAD COLLAPSED DOWN THE BONE COMPLETELY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT IS CONSIDERED TO BE A PREVIOUSLY ADDRESSED DESIGN ISSUE. 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

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED BY THE COMPLAINANT THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL COMPONENT LOOSENING APPROXIMATELY TWO (2) MONTHS POST-OPERATIVELY. INITIAL OPERATIVE NOTES REPORTED THAT THE PATIENT HAD VERY THIN TIBIAL BONE, WHICH REQUIRED ADDITIONAL CUTS FOR IMPLANT PLACEMENT. REVISION OPERATIVE NOTES REPORTED THAT THE IMPLANT WAS CLEARLY LOOSE AT ITS BONE INTERFACE AND HAD COLLAPSED DOWN ON THE BONE COMPLETELY. THE COMPRESS DEVICE WAS REMOVED AND PLACED AGAIN USING FIVE (5) CROSS PINS AND LOADING 600 POUNDS OF COMPRESSION. A CENTERING SLEEVE AND SPINDLE WERE ALSO PLACED TO FIT THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768818 CPS XS SHT SPDL W PINS 800LBF PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 662280

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R SEE H10