BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE

    MDR report key: 14993745 · Received July 12, 2022

    Report

    Report Number
    0001822565-2022-02063
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    September 12, 2017
    Report Date
    August 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). YEAR OF BIRTH: 1945. CONCOMITANT MEDICAL PRODUCTS: 00-5968-014-51, LOT 62577937, NEXGEN LPS FLEX FEMUR D; 00-5980-037-01, LOT 62630914, NEXGEN TIBIA SIZE 3; NEXGEN PATELLA 32MM; UNKNOWN CEMENT. FOREIGN COUNTRY: GERMANY. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE LOCATION OF THE DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT PRESENTS WITH INCREASED PAIN, REDDENING, AND IMMOBILITY OF THE JOINT ACCOMPANIED BY FEVER; INSTABILITY AND LIGAMENT LAXITY NOTED ON EXAM; NO SIGN OF LOOSENING; ARTICULAR SURFACE REPLACED WITHOUT COMPLICATION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 THE PATIENT UNDERWENT INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO PAIN, INSTABILITY, LIGAMENT LAXITY, AND INFECTION. DURING THE REVISION, WIDENING OF THE FLEXION AND EXTENSION GAP WAS NOTED. THE POLY WAS EXCHANGED WITHOUT COMPLICATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    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
    1668570 ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 62561936

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R