BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIH MOD CUP INSERTER

    MDR report key: 12107034 · Received July 2, 2021

    Report

    Report Number
    0001825034-2021-01961
    Event Type
    Malfunction
    Date Received
    July 2, 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. 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 LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED FOR ITEM 31-400600. 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

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

    Additional Manufacturer Narrative · 1

    (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. PART: 010000666, LOT: 6991597, G7 PPS LTD ACET SHELL 58G. PART: 31-400601, LOT: UNK, MIH MOD HNDL 3/8 TIP -SQRE. PART: 31-400603, LOT: UNK, 3/8 THD MOD INSERT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01962.

    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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005313 MIH MOD CUP INSERTER INSTRUMENT, HIP LXH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10