BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL AUGMENT

    MDR report key: 9531984 · Received December 30, 2019

    Report

    Report Number
    0001825034-2019-05804
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    July 9, 2019
    Report Date
    December 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCT(S): 141620 971590 BMT SPLINED KNEE STM 20X80; 183892 482410 VNGD SSK PSC TIB BRG 22X71/75 5 X 22; 183326 723820 VNGD SSK INTLK FMRL 70 LT; 141484 853700 BIOMET OFFSET TIBIAL TRAY 75MM; 141764 146600 BIOMET TIB BLOCK 10MM 75; 141764 146600 BIOMET TIB BLOCK 10MM 75. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS RECEIVED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SURGERY WAS PERFORMED FOR EXPLANATION OF KNEE STEM. INTRAOPERATIVE THERE WAS A DISCONNECTION BETWEEN THE TIBIA SHAFT AND THE TIBIA. PARTIAL DESTRUCTION OF THE PROXIMAL TIBIA WAS NEEDED FOR EXPLANATION. VISUAL EXAMINATION OF THE RETURNED KNEE STEM IDENTIFIED NICKS, GOUGES, AND MARKS CONSISTENT WITH WEAR AND EXPLANTATION. OTHER ITEMS RETURNED INCLUDED ONE VANGUARD FEMORAL, 4 FEMORAL AUGMENT BLOCKS, ONE FEMORAL BEARING, ONE 2.5 MM ADAPTER, ONE BIOMET OFFSET TRAY TIBIA BASE, TWO MAXIM MODULAR TIBIAE IMPLANTS, FOUR LOCK SCREWS, ONE LOCKING BAR, ONE CAP, TWO SCREWS, AND ONE SCREW. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03208, 0001825034 - 2019 - 05797, 0001825034 - 2019 - 05798, 0001825034 - 2019 - 05800, 0001825034 - 2019 - 05802, 0001825034 - 2019 - 05803, 0001825034 - 2019 - 05806, 0001825034 - 2019 - 05807, 0001825034 - 2019 - 05808.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCT. DUE TO INFECTION, THE PATIENT UNDERWENT A 2-STAGE REVISION WITH PLACEMENT OF A CEMENT SPACER ON AN UNKNOWN DATE. THE PATIENT LATER UNDERWENT REMOVAL OF THE CEMENT SPACER WITH PLACEMENT OF AN SSK TOTAL KNEE SYSTEM. SUBSEQUENTLY, THE PATIENT UNDERWENT REMOVAL OF THE SSK SYSTEM DUE TO PERSISTENT PAIN AND CHRONIC OVERLOADING OF THE COLLATERAL LIGAMENTS. ALL PRODUCTS WERE REMOVED AND COMPETITOR PRODUCT PLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327189 UNKNOWN FEMORAL AUGMENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R