BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT STD 28 3 PEG

    MDR report key: 7768224 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07741
    Event Type
    Injury
    Date Received
    August 9, 2018
    Report Date
    October 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEMORAL, CATALOG #: 183000, LOT #: 799400; VANGUARD STABILIZED BEARING, CATALOG #: 183422, LOT #: 088870; BIOMET I-BEAM TRAY, CATALOG #: 141221, LOT #: 673750; BIOMET ARCOM 3 PEG/POST PATELLA, CATALOG #: 184762, LOT #: 093650. 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: 0001822565-2018-07738; 0001822565-2018-07739; 0001822565-2018-07740. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO THE LIMITED INFORMATION PROVIDED BY CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO DEVIATIONS FOUND. ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD ALTER OR CHANGE 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 A PATIENT UNDERWENT PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY. PATIENT WAS NOTED TO HAVE BLOCKED BOWEL REQUIRING VISIT TO ER WHERE INSTABILITY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610575 SERIES A PAT STD 28 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 093650

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention