BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPLINED KNEE STEM 10MM X 80MM

    MDR report key: 6276248 · Received January 25, 2017

    Report

    Report Number
    0001825034-2017-00259
    Event Type
    Injury
    Date Received
    January 25, 2017
    Date of Event
    June 1, 2011
    Report Date
    May 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS - VANGUARD(TM) FEMORAL DISTAL AUGMENT 10MM X 60MM LL/RM, CATALOG# 184202, LOT# 769060. VANGUARD (TM) FEMORAL DISTAL AUGMENT 10MM X 60MM RL/LM, CATALOG# 184182, LOT# 807910. BIOMET SPLINED KNEE STEM 14MM X 120 MM, CATALOG# 141654. LOT# 485730. VANGUARD (TM) FEMORAL POSTERIOR AUGMENT 5MM X 60MM LL/RM, CATALOG# 184162, LOT# 741160. BIOMET OFFSET TIBIAL TRAY ADAPTOR 5.0 MM, CATALOG# 141491, LOT# 326010. VANGUARD (TM) FEMORAL POSTERIOR AUGMENT 5MM X 60 MM RL/LM, CATALOG# 184142, LOT# 668770. BIOMET OFFSET TIBIAL TRAY 63MM, CATALOG# 141481, LOT# 894190. BIOMET SERIES A THIN PATELLA 37MM X 8.6 MM, CATALOG# 184788, LOT# 968230. VANGUARD (TM) DCM TIBIAL BEARING 20MM X 63/67 MM SMALL POST, CATALOG# 183830, LOT# 073550. CUSTOM TITANIUM VANGUARD SSK FEMORAL, CATALOG# CP113123, LOT# 474920. EVENT IS BEING REPORTED TO FDA ON ELEVEN MEDWATCHES SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS REPORT IS NUMBER 5 OF 11 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034 - 2017 - 00253 , 0001825034 - 2017 - 00255 , 0001825034 - 2017 - 00257 , 0001825034 - 2017 - 00258, 0001825034 - 2017 - 00261, 0001825034 - 2017 - 00262 , 0001825034 - 2017 - 00264, 0001825034 - 2017 - 00265 , 0001825034 - 2017 - 00266 ,0001825034 - 2017 - 00267).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS SEVEN (7) MONTHS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59984 BIOMET SPLINED KNEE STEM 10MM X 80MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 298100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R