BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD(TM) DCM CR TIBIAL BEARING ARCOM UHMWPE

    MDR report key: 8125609 · Received December 3, 2018

    Report

    Report Number
    0001825034-2018-10964
    Event Type
    Injury
    Date Received
    December 3, 2018
    Report Date
    July 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. SURGICAL NOTES WERE NOT PROVIDED. 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). CONCOMITANT MEDICAL PRODUCTS: SERIES A STANDARD PATELLA 31 3 PEG ITEM # 184764 LOT # 087590, INTERLOC 71MM FIXED CRUCIATE TIBAL PLATE ITEM # 141233 LOT # 212950, VANGUARD CR ILOK FEMERAL-RT 60 ITEM # 183004 LOT # 397870, COBALT HV BONE CEMENT 40G ITEM # 402282 LOT # 853900. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10962, 0001825034-2018-10963, 0001825034-2018-10965. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY IS EXPERIENCING PAIN, LEG LENGTH DISCREPANCY, BRUISING, DIFFICULTY WALKING AND USES A CANE TO AMBULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965181 VANGUARD(TM) DCM CR TIBIAL BEARING ARCOM UHMWPE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 264490

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other