BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 FREEDOM CONST E1 LNR 36MM G

    MDR report key: 7014600 · Received November 9, 2017

    Report

    Report Number
    0001825034-2017-10091
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 10, 2017
    Report Date
    May 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: BIOMET G7 FREEDOM CONST E1 LNR 36MM E, ITEM#: 010000983, LOT#: 3453158. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION FOUND MULTIPLE FORMS OF DAMAGE, INCLUDING INDENTATIONS, SCRATCHES, AND GOUGES. DEVICE HISTORY RECORD (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

    (B)(4). CONCOMITANT PRODUCTS: 110010284, G7 FREEDOM CONST E1 10DEG LINER 36G, 3532618. 11-107020, FREEDOM CONSTR HD 36MM T1 +6MM, 769940. 11-302101, ARCOS TROCH CLAW LARGE 100MM, 696090. 00625006525, BONE SCR 6.5X25 SELF-TAP, 63585022. 11-302136, ARCOS LATERAL TROCH BOLT 36MM, 489960. 00625006525, BONE SCR 6.5X25 SELF-TAP, 63341510. 00625006520, BONE SCR 6.5X20 SELF-TAP, 63572909. 00625006515, BONE SCR 6.5X15 SELF-TAP, 62411972. 00625006540, BONE SCR 6.5X40 SELF-TAP, 63745010. 00625006530, BONE SCR 6.5X30 SELF-TAP, 63523402. 00625006540, BONE SCR 6.5X40 SELF-TAP, 77002947. 110010268, G7 OSSEOTI MULTIHOLE 60MM G, 6050381. 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: 0001825034 - 2017 - 10092.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER WOULD NOT LOCK INTO THE CUP. TWO DIFFERENT LINERS WERE USED. THERE WAS A 1 HOUR DELAY IN PROCEDURE AS A RESULT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794122 G7 FREEDOM CONST E1 LNR 36MM G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3453182

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other SEE H10 NARRATIVE