BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PATELLA COMPONENTS

    MDR report key: 6540618 · Received May 3, 2017

    Report

    Report Number
    0001825034-2017-02986
    Event Type
    Injury
    Date Received
    May 3, 2017
    Date of Event
    April 18, 2017
    Report Date
    January 15, 2020
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    Z-1858/1863-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCT: PALACOS R RADIOPAQUE BONE CEMENT CATALOG # 00-1112-140-01 LOT # 84624544 QTY: 2.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT-VANGUARD CR ILOK FEMORAL CATALOG# 183006 LOT# J3910141, BIOMET CC CRUCIATE TRAY CATALOG# 141232 LOT# J3846526, VANGUARD AS BEARING CATALOG# 189040 LOT# 312810. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS NOT CONFIRMED AS NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AS PRODUCT WAS STERILIZED AND IT IS UNKNOWN IF THE ELEVATED ENDO-TOXIN LEVELS RESULTED IN THE ELEVATED BACTERIA LEVELS. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REVISION WAS CONFIRMED, BUT THE INFECTION WAS NOT CONFIRMED. THE ADDITIONAL INFORMATION DOES NOT AFFECT THE ROOT CAUSE. MEDICAL RECORD REVIEW INDICATES THAT THE PATIENT HAD RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 DUE TO SEVERE DEGENERATIVE ARTHRITIS. MANIPULATION WAS PERFORMED ON (B)(6) 2017 DUE TO LIMITED ROM. PATIENT UNDERWENT ARTHROTOMY PROCEDURE, REVISED PATELLAR COMPONENT DUE TO SIGNIFICANT OVERGROWTH, CAPSULE WAS DEBRIDED DUE TO THICKENED APPEARANCE AND MEDIAL & LATERAL RELEASE TO INCREASE FLEXION ON (B)(6) 2017. NO FINAL CULTURE RESULTS INDICATING INFECTION. 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

    FROM ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO LIMITED RANGE OF MOTION TWO MONTHS POST OPERATIVE. SUBSEQUENTLY, THE PATIENT REVISED PATELLA PROSTHESIS DUE TO SIGNIFICANT OVERGROWTH, CAPSULE WAS DEBRIDED DUE TO THICKENED APPEARANCE AND MEDIAL AND LATERAL RELEASE TO INCREASE FLEXION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ELEVATED BACTERIA LEVELS FOUR MONTHS POST IMPLANTATION. ONLY THE PATELLA WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323935 VANGUARD PATELLA COMPONENTS PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 605380

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R