BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE G

    MDR report key: 6873791 · Received September 18, 2017

    Report

    Report Number
    0002648920-2017-00576
    Event Type
    Injury
    Date Received
    September 18, 2017
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK122765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. PER THE PERSONA KNEE SYSTEM PACKAGE INSERT, PAIN, JOINT INSTABILITY, AND POOR RANGE OF MOTION ARE KNOWN POTENTIAL ADVERSE EFFECTS OF THIS PROCEDURE. REPORTED INFORMATION STATES THAT THE PATIENT EXPERIENCED A FALL PRIOR TO THE ONSET OF SYMPTOMS; HOWEVER, IT COULD NOT BE CONFIRMED WITH THE AVAILABLE INFORMATION IF THE FALL CONTRIBUTED TO THE EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI: (B)(4). CONCOMITANT PRODUCT(S): P/N 42540000035 ALL POLY PATELLA CEMENTED 35 MM DIAMETER L/N 62869345. P/N 42511200611 ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 11 MM HEIGHT L/N 62747225. P/N 42532007901 TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE G L/N 62979305. P/N 42502606801 FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 10 L/N 62852033 P/N L/N. MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORT: 0002648920 - 2017 - 00574, 0002648920 - 2017 - 00575, 0002648920 - 2017 - 00576, 0001822565 - 2017 - 06424. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS EXPERIENCING EXTREME PAIN POST PRIMARY IMPLANTATION, INSTABILITY, AND THE KNEE LOCKING UP. A REVISION HAS NOT BEEN REPORTED, HOWEVER, IT WAS STATED THE PATIENT IS SCHEDULED FOR AN UNKNOWN PROCEDURE AT AN UNKNOWN DATE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653644 TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE G PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 62979305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention