BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 32MM B

    MDR report key: 14989788 · Received July 12, 2022

    Report

    Report Number
    0001825034-2022-01622
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 17, 2022
    Report Date
    August 5, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527003
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000660 ¿ G7 SHELL ¿ 6991443, 650-1159 ¿ DELTA CERAMIC HEAD ¿ 3069904, 51-100080 ¿ TAPERLOC STEM ¿ 7092040, 110003625 ¿ DELTA CERAMIC LINER ¿ 3100243. REPORT SOURCE: CHINA CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE OUTER RADIUS TO BE DINGED IN 1 LOCATION. A SINGLE LIGHT SCRATCH WAS ALSO OBSERVED ON THE OUTER RADIUS. MORE SIGNIFICANT SCRATCHING WAS FOUND ON THE ELEVATED PORTION OF THE SIDE WALL. NO BARB DAMAGE WAS OBSERVED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. A SUMMARY OF THE INVESTIGATION WAS REQUESTED AND SENT TO THE CUSTOMER. 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

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE LINER WOULD NOT TIGHTEN INTO THE CUP PROPERLY. A NEW LINER WAS USED TO COMPLETE THE SURGERY. THERE WAS NO HARM OR INJURY TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637668 G7 HI-WALL E1 LINER 32MM B PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 7156062 00880304527003

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female SEE H10