BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR LINER HI WALL E1 36MM SIZE G

    MDR report key: 5969963 · Received September 22, 2016

    Report

    Report Number
    0001825034-2016-03758
    Event Type
    Injury
    Date Received
    September 22, 2016
    Date of Event
    August 26, 2016
    Report Date
    July 25, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE FOREIGN: (B)(6). CONCOMITANT MEDICAL PRODUCTS: ITEM# 010000937 G7 HI-WALL E1 LINER 36MM G LOT# 3088478, ITEM# 010000666 G7 PPS LTD ACET SHELL 58G LOT# 3813921. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION NOTED A DIMPLE WAS CREATED AT THE APEX OF THE LINER DURING DISASSEMBLY. A SCRATCHING CAN BE SEEN ON THE LOWER LEFT SIDE OF THE ATTACHED OUTER RADIUS PHOTO. NO DAMAGE CAN BE SEEN ON THE BARB, SCALLOPS, RIM, OR INNER RADIUS OF THE LINER. DIMENSIONAL ANALYSIS ON THE LINER DID NOT FIND ANY RELATED DEVIATIONS/ANOMALIES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND/OR FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03758 / 03759 ).

    Description of Event or Problem · 1

    DURING A TOTAL HIP ARTHROPLASTY, THE LINER WAS IMPACTED AND THOUGHT TO BE SEATED IN THE SHELL. HOWEVER, DURING TRIALING AND RANGE OF MOTION CHECK, THE LINER POPPED OUT OF THE SHELL. THE LINER WAS AGAIN ATTEMPTED TO BE IMPACTED, BUT DISASSOCIATED FROM THE SHELL A SECOND TIME. THE LINER WAS ATTEMPTED TO BE SEATED A THIRD TIME, WITH THE SAME RESULT. A SECOND LINER WAS ATTEMPTED TO BE IMPLANTED; HOWEVER, THE SECOND LINER ALSO WOULD NOT SEAT IN THE SHELL. THE SHELL WAS REMOVED, AND A NEW SHELL AND LINER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS A 15-20 MINUTE DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620608 G7 ACETABULAR LINER HI WALL E1 36MM SIZE G PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A 3530515

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention