BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3/8 THD MOD INSERT

    MDR report key: 12519197 · Received September 23, 2021

    Report

    Report Number
    0001825034-2021-02709
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    June 11, 2021
    Report Date
    November 1, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10. TWO 3/8 THD MOD INSERT ITEM# 31-400603 LOT# ZB180301 WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE TWO THREADED HEADS AND THE DRIVER WERE RETURNED. ONE OF THE HEADS HAD FRACTURED AT THE LOCKING ARM WITH THE FRACTURED PIECE RETURNED. THE DRIVER TOOTH HAD FRACTURED AND WAS NOT RETURNED A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING FOR ITEM 31-400603. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AS TO WHY THE INSERTERS FRACTURED, HOWEVER DURING THE INVESTIGATION IT WAS IDENTIFIED THE ROOT CAUSE OF THE INSERTER NOT PROPERLY FASTENING TO THE CUP WAS RELATED TO THE OFF LABEL USE OF THESE TWO DEVICES AS THEY ARE NOT COMPATIBLE ITEMS. PER THE G7 SURGICAL TECHNIQUE THE GREEN AND BLACK G7 INSERTER IS USED FOR THE FINAL SHELL INSERTION. THE INSERTER INVOLVED WITHIN THIS PROCEDURE IS INTENDED TO BE USED WITH THE RINGLOC + ACETABULAR SYSTEM. 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). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PART: 31-400600, LOT: UNK, MIH MOD CUP INSERTERT PART: 31-400603, LOT: ZB180301, 3/8 THD MOD INSERT PART: 31-400601, LOT: UNK, MIH MOD HNDL 3/8 TIP -SQRE PART: 010000666, LOT: 6991597, G7 PPS LTD ACET SHELL 58G MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01961, 0001825034-2021-02707.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HIP ARTHROPLASTY THE SURGEON NOTICED THAT THE CUP INSERTER WASN¿T PROPERLY FASTENING ONTO THE G7 PPS CUP. THE CUP INSERTER FRACTURED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418250 3/8 THD MOD INSERT INSTRUMENT, HIP LXH ZIMMER BIOMET, INC. N/A ZB180301

    Patients

    Seq Age Sex Outcome Treatment
    1