BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL 9X137

    MDR report key: 7564589 · Received June 4, 2018

    Report

    Report Number
    0001825034-2018-03711
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    November 11, 2016
    Report Date
    February 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034-2018-03391, 0001825034-2018-03392. REVIEW OF INVOICE HISTORY WAS UNABLE TO DETERMINE THE EXACT IDENTIFICATION OF THE DEVICE INVOLVED IN THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED FOR: BRAND NAME ¿ TAPERLOC POR FMRL, CATALOG NUMBER ¿ 103203, LOT NUMBER ¿ 305410, EXPIRATION DATE ¿ NOV 30, 2013, DEVICE MANUFACTURE DATE - NOV 4, 2003, OR BRAND NAME ¿ M2A MODULAR HEAD 38MM -6 NECK, CATALOG NUMBER ¿ 162307, LOT NUMBER ¿ 966440, EXPIRATION DATE ¿ UNKNOWN AT THIS TIME, DEVICE MANUFACTURE DATE - UNKNOWN AT THIS TIME. CONCOMITANT MEDICAL PRODUCTS: BRAND NAME ¿ M2A MODULAR HEAD 38MM -6 NECK, CATALOG NUMBER ¿ 11-173660, LOT NUMBER ¿ 430130, EXPIRATION DATE ¿ DEC 31, 2013, DEVICE MANUFACTURE DATE - DEC 31, 2003 OR BRAND NAME ¿ M2A MODULAR HEAD 38MM -6 NECK, CATALOG NUMBER ¿ 11-163667, LOT NUMBER ¿ 335980, EXPIRATION DATE ¿ JAN 31, 2014, DEVICE MANUFACTURE DATE - JAN 1, 2004. CATALOG# RD118856, M2A 38MM CUP, LOT# 330980, OR CATALOG# 15-105004, M2A TAPER LINER, LOT# 963340, CATALOG# 103203, TAPERLOC POR FMRL 9X137, LOT# 305410 OR CATALOG# 162307, BI-METRIC CDH POR N/C 7X114, LOT# 966440. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR FOR BOTH DEVICES 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS PAIN. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407651 TAPERLOC POR FMRL 9X137 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R