BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE REGULAR CONSTRAINT

    MDR report key: 7801045 · Received August 21, 2018

    Report

    Report Number
    0001822565-2018-04025
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    March 12, 2018
    Report Date
    February 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 04026 - 1.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT EXPERIENCED FLEXION CONTRACTURE THREE MONTHS POST-IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: NONAUGMENTABLE STEMMED TIBIAL COMPONENT PART#: 00598603702, LOT#: 63851973; ALL POLY PATELLA PART#: 00597206532, LOT#: 63760719. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS AND 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: 0001822565 - 2018 - 04025, 0001822565 - 2018 - 04026. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY THREE MONTHS POST-IMPLANTATION DUE TO OSTEARTHRITIS. SUBSEQUENTLY, THE PATIENT SUFFERED FLEXION CONTRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644639 ARTICULAR SURFACE REGULAR CONSTRAINT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR