BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 44MM F

    MDR report key: 10397610 · Received August 12, 2020

    Report

    Report Number
    0001825034-2020-03115
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    March 3, 2020
    Report Date
    August 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    UDI-DI
    00880304703520
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET ACT ARTIC E1 HIP BRG 28X44MM CAT#: EP-200150, LOT# 885270. ZIMMER HEAD CAT# 00801802803, LOT#64482573. BIOMET G7 OSSEOTI 4 HOLE SHELL 54MM F CAT# 110010245, LOT# 6683804. ZIMMER FEMORAL STEM FIBER METAL MIDCOAT COLLARED CEMENTLESS 12/14 NECK TAPER STANDARD NECK OFFSET SIZE 15 STANDARD BODY 15 MM DISTAL STEM DIAMETER 160 MM STE CAT#00784101500, LOT#64311861. BIOMET G7 SUCTION CUP STERILE CAT#110010571, LOT#575810. REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS PROVIDED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: DISLOCATION RIGHT HIP AND UNSTABLE, OPEN REDUCTION OF RIGHT HIP, HEMATOMA EVACUATED (THIS WOULD BE DUE TO THE DISLOCATION), FOUND POLY BEARING HAD COME OFF FEMORAL HEAD FROM THE TRUNNION, NO DEFECTS WITH TRUNNION OR ACETABULUM COMPONENT, 20 DEGREES OF ANTEVERSION AND 45 DEGREES OF ABDUCTION, REMOVED FEMORAL HEAD, NO OTHER COMPLICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01290.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT HIP ARTHROPLASTY. APPROXIMATELY 2 WEEKS LATER PATIENT WENT TO SIT DOWN AND TWISTED BACK AND FELT A POP. THE PATIENT WAS REDUCED, BUT IT WAS JUST THE METAL HEAD IN THE CUP SANS POLY. WHEN THE SURGEON OPENED HIM UP, THE POLY WAS DISASSOCIATED FROM THE FEMORAL HEAD. THE SURGEON FELT THE IMPLANTS WERE ACCEPTABLE. THE IMPLANTS WERE REASSEMBLED AND THE HIP REDUCED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861471 G7 DUAL MOBILITY LINER 44MM F PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 776200 00880304703520

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R