BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10 NARRATIVE

    MDR report key: 8137446 · Received December 6, 2018

    Report

    Report Number
    0001822565-2018-06638
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 9, 2018
    Report Date
    July 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RETURNED HEADS WHICH INDICATE BIOMET HEADS WERE USED WITH ZIMMER STEM. BIOMET HEAD IS NOT COMPATIBLE WITH ZIMMER STEM. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO INTENTIONAL OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE-USER ERROR. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). FEMORAL STEM BEADED FULLCOAT 12/14 NECK TAPER STD. BODY STD. OFFSET SIZE 16 16 MM DISTAL DIA. 160 MM LENGTH. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 00877502801 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 28/-3.5, TAPER 12/14 LOT# 2944874. ITEM# 14-107017 FRDM CNSTR HD 36MM T12/14 -3MM LOT# 182610. ITEM# 14-107018 FRDM CNSTR HD 36MM T12/14 STD LOT# 112320. ITEM# 010000984 G7 FREEDOM CONST E1 LNR 36MM F LOT# 3266331. ITEM# 110010245 G7 OSSEOTI 4 HOLE SHELL 54MM F LOT# 6336052. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TAPER ON THE STEM WOULD NOT ENGAGE WITH THE FEMORAL HEAD. DUE TO THIS ISSUE THE LINER WAS REMOVED, AND A DIFFERENT LINER WAS IMPLANTED. DELAY OF PROCEDURE: 60 MINUTES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WAS MADE; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976836 SEE H10 NARRATIVE PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 77005813

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O