BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE

    MDR report key: 11086853 · Received December 29, 2020

    Report

    Report Number
    0001032347-2020-00631
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    December 3, 2020
    Report Date
    March 9, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036054564
    PMA / PMN Number
    K955729
    Removal / Correction Number
    N/A
    Adverse Event
    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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS AND STERILE CERTIFICATES IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. 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

    ZIMMER BIOMET COMPLAINT (B)(4). 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: 0001032347-2020-00629, 0001032347-2020-00630, 0001032347-2020-00632, 0001032347-2020-00633. EXPLANTATION DATE ¿ THE CUSTOMER REPORTED TWO DATES FOR THE REVISION SURGERY: (B)(6) 2020. CLARIFICATION WAS REQUESTED FROM THE CUSTOMER AND NO RESPONSE HAS YET BEEN RECEIVED. MEDICAL PRODUCTS: 2.0 LACTOSORB SYSTEM L-PLATE - RIGHT - REGULAR, PART# 915-2101, LOT# 835610. 2.0 LACTOSORB SYSTEM STRAIGHT PLATE - 6 HOLE, PART# 915-2109, LOT# 956850. 2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE, PART# 915-2111, LOT# 145750. 2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE, PART# 915-2111, LOT# 372990. 2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 6 HOLE, PART# 915-2112, LOT# 499780. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFECTION AND INFLAMMATION WERE DISCOVERED NINE (9) DAYS FOLLOWING IMPLANTATION OF PLATES AND SCREWS AND A REMOVAL WAS PLANNED TWO (2) WEEKS FOLLOWING IMPLANTATION. THE SURGEON IS UNCERTAIN AS TO THE CAUSE OF THE INFECTION AND THINKS IT IS POSSIBLE THAT THE PLATES AND SCREWS ARE THE CAUSE OF THE INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554691 2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 145750 00841036054564

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R