BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VANGUARD TIBIAL BEARING CR

    MDR report key: 7299939 · Received February 27, 2018

    Report

    Report Number
    0001825034-2018-01452
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    May 30, 2014
    Report Date
    March 8, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS, HOWEVER, NO DEVICES WERE RECEIVED, THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: BIOMET CC I-BEAM TRAY CAT#: 141223, LOT#: J3203376 VANGUARD CR FEMORAL CAT#: 183048, LOT#: 973000 BIOMET MODULAR TIBIAL LOCKING BAR CAT#: 141205, LOT#: 984430 BIOMET SERIES THIN PATELLA CAT #: 184786, LOT#: 540530 COBALT BONE CEMENT CAT# 402283, LOT# 611100.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SOUGHT MEDICAL INTERVENTION FOR ONGOING PAIN AND SWELLING FOR 3 YEARS POSTOP WITHOUT RELIEF. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AND SWELLING POST RIGHT TOTAL KNEE ARTHROPLASTY. FOLLOW UP VISITS WITH SURGEONS HAVE NOT IDENTIFIED AN ISSUE WITH THE IMPLANTS AND THE PATIENT HAS UNSUCCESSFULLY ATTEMPTED PAIN MANAGEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4) THIS EVENT WAS REPORTED TO THE FDA PREVIOUSLY VIA MW5073592. CONCOMITANT MEDICAL PRODUCTS: BIOMET CC I-BEAM TRAY CAT#: 141223, LOT#: J3203376. VANGUARD CR FEMORAL CAT#: 183048, LOT#: 973000. BIOMET MODULAR TIBIAL LOCKING BAR CAT#: 141205, LOT#: 984430. BIOMET SERIES THIN PATELLA CAT #: 184786, LOT#: 540530. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01453, 0001825034 - 2018 - 01454, 0001825034 - 2018 - 01455, 0001825034 - 2018 - 01456.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND SWELLING AFTER INITIAL KNEE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142492 E1 VANGUARD TIBIAL BEARING CR PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 750180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention