BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 54MM I

    MDR report key: 8653518 · Received May 30, 2019

    Report

    Report Number
    0001825034-2019-02363
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    April 17, 2019
    Report Date
    October 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI# (B)(4). REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS AND X RAYS. PRODUCT WAS RETURNED. UPON VISUAL INSPECTION THE OUTSIDE DIAMETER OF THE BARING SHOWS CIRCULAR MARKS THAT CAN BE FELT WITH YOUR FINGER. THE HEAD SHOWS SCUFFING AND WEAR. THERE ARE VISIBLE SCUFF MARKS ON THE INSIDE DIAMETER OF THE LINER ALONG WITH TWO BURRS ON THE LIP. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 0

    OPERATIVE NOTES WERE PROVIDED. REVIEW OF THE NOTES DEMONSTRATED SUBFASCIAL ADHESIONS DUE TO PREVIOUS INCISIONS, REDDISH SYNOVIAL FLUID NOTED (UNREMARKABLE), ADDUCTOR TENOTOMY PERFORMED DUE TO LIMITED RANGE OF MOTION PER PATIENT ANATOMY, NO INTRAOP COMPLICATIONS NOTED. ADDITIONAL INFORMATION DOES NOT CHANGE THE PREVIOUS SUMMERY.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCT. THE PATIENT WAS REVISED TO AN ARCOS REVISION SYSTEM APPROXIMATELY 1 YEAR LATER. SUBSEQUENTLY, IT WAS NOTED DURING AN OFFICE VISIT APPROXIMATELY 1 YEAR LATER, THE PATIENT SUSTAINED MULTIPLE DISLOCATIONS AND WAS REDUCED IN THE EMERGENCY DEPARTMENT. IT WAS FURTHER REPORTED THAT DURING THE REDUCTION, THE G7 BEARING DISASSOCIATED FROM THE BIOLOX HEAD. THIS LED TO A SECOND REVISION OF THE RIGHT HIP. PATIENT INSTRUCTED TO CONTINUE PHYSICAL THERAPY BUT AVOID THE MOTIONS THAT CAUSE DISLOCATION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET BIOLOX HEAD CAT#12-115109 LOT#2886313, BIOMET BEARING CAT#EP-200160 LOT#211710, BIOMET G7 CUP CAT#110010271 LOT#3983154, BIOMET STEM CAT#11-301300 LOT#946930, BIOMET TAPER CAT#11-300920 LOT#013480. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 02362, 0001825034 - 2019 - 02364.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 1 YEAR POST THA. IT WAS REPORTED DURING AN OFFICE VISIT APPROXIMATELY 1 YEAR LATER, THAT THE PATIENT SUSTAINED MULTIPLE DISLOCATIONS AND WAS RECENTLY REDUCED IN THE EMERGENCY DEPARTMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447122 G7 DUAL MOBILITY LINER 54MM I PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 058910

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R