BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 32MM F

    MDR report key: 7901714 · Received September 24, 2018

    Report

    Report Number
    0001825034-2018-08990
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    August 22, 2018
    Report Date
    June 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION OF LINER IDENTIFIED DAMAGES IN THE FORM OF SCRATCHES AND GOUGES ON THE RIM OF THE LINER. THE SCALLOPS OF THE LINER WERE DAMAGED LIKELY CAUSED DURING AN ATTEMPT TO IMPACT THE LINER WITH THE SHELL. THE OUTER DIAMETER AND THE LOCKING FEATURES WERE HEAVILY DAMAGED IN THE FORM OF GOUGES AND SCRATCHES. THESE DAMAGES WERE LIKELY CAUSED DURING EXTRACTION AND IMPACTION OF THE LINER. THE LINER WAS 100% INSPECTED DURING MANUFACTURING AND WAS CONFORMING TO PRINT SPECIFICATIONS. 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 · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#010000664 G7 PPS LTD ACET SHELL 54F LOT# 6335888, ITEM# 650-1163 DELTA CER FEM HD 32/-3MM T1 LOT# 3782006, ITEM# 51-113140 TPRLC 133 TYPE1 BM SO 14.0 LOT# 3782006. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# UNKNOWN UNKNOWN SHELL LOT# UNKNOWN . (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY PROCEDURE THE LINER DISASSOCIATED FROM THE SHELL MULTIPLE TIMES. PROCEDURE WAS COMPLETED WITH A DIFFERENT LINER. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744079 G7 HI-WALL E1 LINER 32MM F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6209101

    Patients

    Seq Age Sex Outcome Treatment
    1