BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPLINED KNEE STEM

    MDR report key: 6784569 · Received August 10, 2017

    Report

    Report Number
    0001825034-2017-06246
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    November 16, 2015
    Report Date
    January 31, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK121149
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR SUPPLEMENTAL REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05984. CONCOMITANT MEDICAL PRODUCTS - VANGUARD-BEARINGS-UNK CATALOG # UNKNOWN LOT # UNKNOWN, VANGUARD-FEMORALS-UNK CATALOG # UNKNOWN LOT # UNKNOWN, VANGUARD-TIBIAL TRAYS-UNK CATALOG # UNKNOWN LOT # UNKNOWN, UNKNOWN VANGUARD BEARING CATALOG # UNKNOWN, LOT # UNKNOWN. (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT - BMT 360 7.5 MM OFFSET ADAPTER CATALOG# 185212 LOT# 902910, VNGD SSK PSC TIB BRG 14X71/75 CATALOG# 183884 LOT# 246660, VNGD SSK 360 L FEM 65 MM CATALOG# 185284 LOT# 3341254, BMT 360 TIB TRAY 71 MM CATALOG# 185203 LOT# 286160, VG 360 DST FM AG 65X5 LL/RM CATALOG# 185324 LOT# 308240, BMT 360 TIB 5.0 OFFSET ADAPTER CATALOG# 185211 LOT# 102670, BMT SPLINED KNEE STM 20X80 CATALOG# 141620 LOT# 303550. 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 AS NO WERE TRENDS 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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE AND SUBSEQUENTLY WAS REVISED DUE TO LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCE WAS REPORTED. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING OF STEM FROM OFFSET ADAPTOR, THEREBY CAUSING A BONE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564324 BIOMET SPLINED KNEE STEM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 948720

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R