BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 FREEDOM CONST E1 LNR 36MM G

    MDR report key: 16844981 · Received May 1, 2023

    Report

    Report Number
    0001825034-2023-00907
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    April 4, 2023
    Report Date
    July 13, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304989092
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED} UPDATED: D9; G3; H2; H3; H6 VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THERE ARE INDENTATIONS ON THE OD AND TO THE LOCKING FEATURE OF THE DEVICE. IT IS UNKNOWN IF THE DAMAGE OCCURRED DURING OR PRIOR TO THE ASSEMBLY ATTEMPTS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. 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

    (B)(4). D10: CAT# 31-323250, LOT# 534200, 3.2MMX50MM RNGLC+ ACET DRL BIT; CAT# 00-6250-065-20, LOT# J7415447, BONE SCREW 6.5X20 SELFTAP; CAT# 11-300816, LOT# 097220, ARCOS 16X150MM SPL TPR DIST; CAT# 110010267, LOT# 65375071, G7 OSSEOTI MULTIHOLE 58MM G; CAT# 00-6250-065-20, LOT# 65349395, BONE SCREW 6.5X20 SELFTAP; CAT# 00-6250-065-60, LOT# 65746064, BONE SCREW 6.5X60 SELFTAP; CAT# 00-6250-065-15, LOT# J7131464, BONE SCREW 6.5X15 SELFTAP; CAT# 00-6250-065-20, LOT# J7426206, BONE SCREW 6.5X20 SELFTAP; CAT# 00-6250-065-20, LOT# J7161142, BONE SCREW 6.5X20 SELFTAP; CAT# 110031001, LOT# 65475291, LONGEVITY DM BEARING 28X46MM; CAT# 11-301332, LOT# 273820, ARCOS CON SZ B HI 70MM; CAT# 110024465, LOT# 239830, G7 DUAL MOBILITY LINER 46MM G; CAT# 650-1158, LOT# 3133312, DELTA CER FEM HD 28/0MM T1. THE 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 · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 58 MULTIHOLE G7 CUP WAS PLACED IN THE ACETABULUM WITH SCREWS. A FREEDOM LINER WAS REQUESTED, AND A G FREEDOM LINER WAS USED. THE LINER WOULD NOT ENGAGE AFTER 4 ATTEMPTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522673 G7 FREEDOM CONST E1 LNR 36MM G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 7037178 00880304989092

    Patients

    Seq Age Sex Outcome Treatment
    1 Female