BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER CENTERPULSE TIBIAL INSERT NK CONGR. A/9 R

    MDR report key: 6860987 · Received September 13, 2017

    Report

    Report Number
    0001822565-2017-06367
    Event Type
    Injury
    Date Received
    September 13, 2017
    Report Date
    October 26, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK931651
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DOB: (B)(6). CONCOMITANT MEDICAL PRODUCTS ¿ UNKNOWN ZIMMER TIB. BASEPLATE NK W/STEM NP 2, CATALOG #: 6300-00-420, LOT #: UNKNOWN. (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED,A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN FEMUR CATALOG # UNKNOWN, LOT # UNKNOWN; NP STM TIB W/SCW HOLE SZ2 NATURAL-KNEE CATALOG # 6300-00-420 LOT # UNKNOWN. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL KNEE ARTHROPLASTY ON UNKNOWN DATE, SUBSEQUENTLY, THE PATIENT WILL BE REVISED FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS SCHEDULED FOR A RIGHT TOTAL KNEE REVISION SURGERY APPROXIMATELY 19 YEARS POST PRIMARY SURGERY, DUE TO POLY WEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642596 ZIMMER CENTERPULSE TIBIAL INSERT NK CONGR. A/9 R PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R