BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY

    MDR report key: 7236542 · Received February 2, 2018

    Report

    Report Number
    0001825034-2018-00627
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    May 13, 2017
    Report Date
    March 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN VANGUARD KNEE FEMORAL CAT#: UNK, LOT#: UNK; UNKNOWN VANGUARD KNEE BEARING CAT#: UNK, LOT#: UNK. 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: 0001825034-2018-00625, 0001825034-2018-00625, 0001825034-2018-00625. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 189080 LOT: 231910 VNGD ANT STBLZD BRG 10X75, 11-150826 LOT: 058090 BMET ARCO AP PAT W/WIRE 31MM, 141224 LOT: J3964019 BIOMET CC I-BEAM TRAY 75MM, 183028 LOT: J3976254 VANGUARD ANT STBLZD BRG 14X71, 11-150826 LOT: 180930 BMET ARCO AP PAT W/WIRE 31MM, 183008 LOT: J6000516 VANGUARD CR ILOK FEM-RT 65, 141224 LOT: J3960661 BIOMET CC I-BEAM TRAY 75MM, 189080 LOT: 093890 VNGD ANT STBLZD BRG 10X75. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: LOT NUMBER - J3964019, EXPIRATION DATE - JAN 26, 2027, MANUFACTURE DATE ¿ JAN 26, 2017. OR THE PART/LOT INFORMATION COULD BE: LOT NUMBER - J3960661, EXPIRATION DATE - JAN 17, 2027, MANUFACTURE DATE ¿ JAN 17, 2017. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER.DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 IRRIGATION AND DETRIMENT SIX WEEKS AFTER INITIAL KNEE PROCEDURE DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT EXPERIENCED AN INFECTION WITH WOUND DRAINAGE APPROXIMATELY SIX WEEKS POST-INITIAL IMPLANTATION. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL TO UNDERGO AN IRRIGATION AND DEBRIDEMENT PROCEDURE. A SUPERFICIAL INCISION WAS MADE AND IT WAS NOTED THAT THE KNEE CAPSULE WAS INTACT. THE PATIENT HAD A PICC LINE INSERTED AND WAS ON ANTIBIOTICS FOR APPROXIMATELY TWO WEEKS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81982 BIOMET CC I-BEAM TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R