BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM POR ANA PRI FML 60 RT

    MDR report key: 9123756 · Received September 26, 2019

    Report

    Report Number
    0001825034-2019-04311
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    September 6, 2019
    Report Date
    January 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT WAS NOT CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED SUBTLE JOINT SPACE NARROWING IN THE MEDIAL COMPARTMENT THAT COULD BE RELATED TO POLY WEAR. THIN RIM OF PERIPROSTHETIC LUCENCY MEDIAL TO THE MEDIAL FEMORAL CONDYLE COULD BE ARTIFACTUAL OR POSSIBLE LOOSENING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE HOSPITAL WOULD NOT ALLOW THE RETURN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 11-146152, LOT # 621960; ITEM # 141233, LOT # 770280; ITEM # 11-150828, LOT # 723840. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04310.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY, SUBSEQUENTLY PATIENT WAS REVISED DUE TO POLY WEAR AND OSTEOLYSIS CAUSING FEMORAL LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920192 MAXIM POR ANA PRI FML 60 RT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 940850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R