BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK PSC TIB BRG 18X63/67

    MDR report key: 6865559 · Received September 14, 2017

    Report

    Report Number
    0001825034-2017-07101
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    August 23, 2017
    Report Date
    October 6, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: VNGD SSK PSC TIB BRG 18X63/67 CATALOG# 183868 LOT#804800. VNGD SSK INTLK FMRL 65 RT CATALOG# 183304 LOT# 808020. BIOMET OFFSET TIBIAL TRAY 67 MM CATALOG# 141482 LOT# 212320. SERIES A PAT STD 31 3 PEG CATALOG# 184764 LOT# 658900. BIOMET TIB BLOCK 10 MM 67 CATALOG# 141762 LOT# 947920. BMT SPLINED KNEE STM 10X80 CATALOG# 141610 LOT # 171970. BMT SPLINED KNEE STM 14X80 CATALOG# 141614 LOT# 544380. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 THE PATIENT UNDERWENT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645299 VNGD SSK PSC TIB BRG 18X63/67 KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 804800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNK, UNKNOWN VANGUARD FEMORAL, UNK| UNK, UNKNOWN VANGUARD PATELLA, UNK| UNK, UNKNOWN VANGUARD TIBIAL TRAY, UNK