BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 FREEDOM AND OFFSET LINERS, FREEDOM HEAD, SIZE 32

    MDR report key: 6429932 · Received March 23, 2017

    Report

    Report Number
    0001825034-2017-01732
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 20, 2017
    Report Date
    June 29, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK142882
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE LINER FOUND MULTIPLE FORMS OF DAMAGE. THE RIM OF THE LINER AND THE RIM OF THE OFFSET PORTION OF THE LINER ARE GOUGED, LIKELY DUE TO THE INSERTION AND REMOVAL OF THE DEVICES. THE RADIUS IS ALSO COVERED WITH SMALL PITS AND INDENTATIONS. THE PITTING AND SCUFFING INDICATE THAT THERE MAY HAVE BEEN DEBRIS BETWEEN THE LINER AND CUP AT THE TIME OF INSERTION. X-RAYS WERE PROVIDED AND REVIEWED. X-RAY REVIEW STATED PARTIAL UNCOVERING OF THE ACETABULAR CUP. THE RING ASSOCIATED WITH THE CUP LINER IS ORIENTED SHOWING POSSIBLE LOOSENING OR TILTING. HOWEVER, A LINER WEAR IS NOT CONFIRMED DURING THE INITIAL STAGE. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED (B)(4). CONCOMITANT PRODUCTS: 14-107021 896680 FRDM CNSTR HEAD 36MM T12/14 +9MM. THE DEVICE HAS RETURNED FOR ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED 4 MONTHS POST-IMPLANTATION DUE TO WEAR OF THE LINER. 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
    212205 G7 FREEDOM AND OFFSET LINERS, FREEDOM HEAD, SIZE 32 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 3579740

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O