BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SERIES A STANDARD PATELLA - ARCOM UHMWPE

    MDR report key: 8125433 · Received December 3, 2018

    Report

    Report Number
    0001825034-2018-10962
    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: BIOMET CC CRUCIATE TRAY 71MM, ITEM # 141233, LOT # 212950; VANGUARD CR TIBIAL BEARING 10X71/75, ITEM # 183440, LOT # 264490; 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: 0001825034-2018-10963, 0001825034-2018-10964, 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 HAS TO USE A CANE TO AMBULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965408 BIOMET SERIES A STANDARD PATELLA - ARCOM UHMWPE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 087590

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other