BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIST TIB ANTLAT R NRW 12H STE

    MDR report key: 8874202 · Received August 8, 2019

    Report

    Report Number
    0001825034-2019-03243
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    July 10, 2019
    Report Date
    January 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K111663
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTION WAS CORRECTED: D11. 856135030 3.5X30MM CORT LOCK SCR STE 452510, 856135032 3.5X32MM CORT LOCK SCR STE 532730, 856135032 3.5X32MM CORT LOCK SCR STE 774040, 856135034 3.5X34MM CORT LOCK SCR STE 120400, 856135040 3.5X40MM CORT LOCK SCR STE 120550, 856135040 3.5X40MM CORT LOCK SCR STE 939680, 856135042 3.5X42MM CORT LOCK SCR STE 149770, 856135042 3.5X42MM CORT LOCK SCR STE 433990. 851235018 3.5X18MM LOW PRO CORT SCR STE 883080 851235032 3.5X32MM LOW PRO CORT SCR STE 222000 851218000 3.5MM LOW PRO CORT WASHER STE 558360 851218000 3.5MM LOW PRO CORT WASHER STE 955000 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 001825034 - 2019 - 03446-1, 0001825034 - 2019 - 04058, 0001825034 - 2019 - 04059, 0001825034 - 2019 - 04060, 0001825034 - 2019 - 04062, 0001825034 - 2019 - 04063, 0001825034 - 2019 - 04065, 0001825034 - 2019 - 04066, 0001825034 - 2019 - 04069, 0001825034 - 2019 - 04070. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE TIBIAL AND FIBULAR ARE FRACTURED. FRACTURE OF THE TIBIAL PLATE AND THE MOST PROXIMAL TIBIAL FIXATION SCREW. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CONCOMITANT MEDICAL PRODUCTS: UNK SCREW. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 03446.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INITIAL SURGERY WAS PERFORMED WITH ALPS PLATES AND SCREWS. TO FIX THE DISTAL TIBIAL BONE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO FRACTURE OF THE PLATE AND PROXIMAL TIBIAL SCREW. THE PATIENT'S BONE DID NOT HEAL AS EXPECTED POST INITIAL PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667969 DIST TIB ANTLAT R NRW 12H STE PLATE, FIXATION, BONE HSB ZIMMER BIOMET, INC. 688520

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R