BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 DUAL MOBILITY LINER 44MM F

    MDR report key: 12165639 · Received July 14, 2021

    Report

    Report Number
    0001825034-2021-02075
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 28, 2021
    Report Date
    September 23, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304703520
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D9; G3; H2; H3; H6    A G7 DUAL MOBILITY LINER 44MM F WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE NIPPLE TO BE SCRATCHED AND DINGED. SCUFFING WAS OBSERVED ON THE OUTER RADIUS. SCRATCHING IS PRESENT ON THE INNER RADIUS. THE LINER APPEARS TO REMAIN VISUALLY ROUND WITH NO MAJOR DENTING OR DEFORMATION. THE DAMAGES ARE LIKELY CAUSED DURING AN ATTEMPT TO IMPACT THE LINER WITH THE CUP. THE DIMENSIONAL ANALYSIS OF THE LINER WERE CONFORMING TO SPECIFICATIONS DURING MANUFACTURING. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    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 NUMBER: 010000998, ITEM NAME: G7 SCREW 6.5MM X 25MM, LOT # :6781028. ITEM NUMBER: 010000664, ITEM NAME: G7 PPS LTD ACET SHELL 54F, LOT #: 6966376. ITEM NUMBER: 010000997, ITEM NAME: G7 SCREW 6.5MM X 20MM, LOT #: 6865828. ITEM NUMBER: 110031012, ITEM NAME: VIVACIT-E DM BEARING28X44MM, LOT #: 65016414. ITEM NUMBER: 163663, ITEM NAME: 28MM DIA COCR MOD HD +3MMNK, LOT #: 745650. ITEM NUMBER: 192414, ITEM NAME: ECHO POR FMRL RED NC14X150MM, LOT #: 803590. ITEM NUMBER: 110024464, ITEM NAME: G7 DUAL MOBILITY LINER 44MMF, LOT #: 403780. ITEM NUMBER: 31-323220, ITEM NAME: 3.2MMX20MM RNGLC+ ACETDRL BIT, LOT #: 444760. 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 THE SURGEON ATTEMPTED TO IMPACT THE METAL DUAL MOBILITY LINER INTO THE CUP, BUT WAS UNABLE TO SECURE IT. A FEW ATTEMPTS WERE MADE. THE LINER LOOKED SLIGHTLY CANTED AND AFTER SEVERAL ATTEMPTS THERE WAS A DING/SCRATCH TO THE NIPPLE OF THE METAL LINER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066595 G7 DUAL MOBILITY LINER 44MM F PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 304750 00880304703520

    Patients

    Seq Age Sex Outcome Treatment
    1