BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOMET 360 OFFSET ADAPTER WITH SCREWS 7.5MM

    MDR report key: 8086306 · Received November 19, 2018

    Report

    Report Number
    0001825034-2018-10748
    Event Type
    Death
    Date Received
    November 19, 2018
    Date of Event
    November 14, 2018
    Report Date
    August 6, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: SERIES-A STANDARD PATELLA 34MM X 8.5MM, CATALOG #: 184766, LOT #: 409610. BIOMET SPLINED KNEE STEM V2 WITH SCREW 18MM X 40MM, CATALOG #: 148293 ,LOT #: 269100. VANGUARD SSK 360 FEMORAL COMPONENT LEFT 72.6MM, CATALOG #: 185287, LOT #: 6053604. VANGUARD 360 REVISION POSTERIOR AUGMENT WITH BOLT, CATALOG #: 185347, LOT #: 862360, 5MM X 72.5MM. VANGUARD 360 REVISION DISTAL FEMORAL AUGMENT WITH BOLT 5MM X 72.5MM, CATALOG #: 185307, LOT #: 186000. BIOMET 360 TIBIAL TRAY 79MM, CATALOG #: 185205, LOT #: 883210. BIOMET 360 TIBIAL CRUCIATE WING, CATALOG #: 185651, LOT #: 700880. BIOMET 360 OFFSET ADAPTER 2.5MM, CATALOG #: 185210, LOT #: 371710. BIOMET 360 TIBIAL AUGMENT 10MM X 79MM, CATALOG #: 185235, LOT #: 830830. BIOMET SPLINED KNEE STEM V2 WITH SCREW 17MM X 40MM, CATALOG #: 148292, LOT #: 945540. VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 12MM X 79/83MM, CATALOG #: 185102, LOT #: 449000. VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 12MM X 79/83MM, CATALOG #: 185102, LOT #: 237190. BIOMET TIBIAL LOCKING BAR, CATALOG #: 141205, LOT #: 966260. VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 12MM X 79/83MM, CATALOG #: 185102, LOT #: 055590. BIOMET TIBIAL LOCKING BAR, CATALOG #: 141205, LOT #: 478950. VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 12MM X 79/83MM, CATALOG #: 185102, LOT #: 018270. BIOMET TIBIAL LOCKING BAR, CATALOG #: 141205, LOT #: 889430. VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 12MM X 79/83MM, CATALOG #: 185102, LOT #: 018270. BIOMET TIBIAL LOCKING BAR, CATALOG #: 141205, LOT #: 588070. TIBIAL KNEE CEMENT MOLD 80MM, CATALOG #: 433180, LOT #: 014870. FEMORAL KNEE CEMENT MOLD 70MM, CATALOG #: 432170, LOT #: 202630. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE DEVICE REMAINS UNKNOWN AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF THE STERILE CERTIFICATES INDICATES THAT THE PRODUCTS WERE STERILE WHEN THEY WERE RELEASED FROM ZIMMER BIOMET CONTROL. 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 PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2018-10745, 0001825034-2018-10746, 0001825034-2018-10747, 0001825034-2018-10749, 0001825034-2018-10750, 0001825034-2018-10751, 0001825034-2018-10752, 0001825034-2018-10753, 0001825034-2018-10754, 0001825034-2018-10755.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY AND DEVELOPED A STAPHYLOCOCCUS AUREUS INFECTION THREE (3) WEEKS POST-OPERATIVELY. THE PATIENT UNDERWENT MULTIPLE POLYETHYLENE BEARING REPLACEMENTS WITH IRRIGATION AND DEBRIDEMENT PROCEDURES. AS THE INFECTION CONTINUED, THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION AND SPACER MOLDS WERE IMPLANTED. IT WAS NOTED DURING THE REVISION PROCEDURE THAT THE PATIENT HAD NECROSIS ON THE INCISION AS WELL AS THE PATELLA. APPROXIMATELY THREE WEEKS LATER, THE PATIENT UNDERWENT A BELOW THE KNEE AMPUTATION. SIX DAYS FOLLOWING THE AMPUTATION, THE PATIENT EXHIBITED RHEUMATOID ARTHRITIS IN THE LUNGS, A DECREASE IN VITAL SIGNS AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924532 BIOMET 360 OFFSET ADAPTER WITH SCREWS 7.5MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 289130

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R