BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 FINNED 4 HOLE SHELL 54F

    MDR report key: 11684464 · Received April 19, 2021

    Report

    Report Number
    0001825034-2021-01105
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 20, 2021
    Report Date
    July 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQI
    UDI-DI
    0088030452931
    PMA / PMN Number
    K142746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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: D4 UDI#,;D9; G3; H2; H3; H6 VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED LINER 6744972 HAS SCUFFING NEAR THE SCALLOP LOCATION BUT NO FURTHER DAMAGE TO THE DEVICE. LINER 6617746 LOCKING FEATURE HAS VISIBLE SHAVING. THERE WAS NO VISIBLE DAMAGE TO THE RETURNED SHELL. THE SHELL AND LINERS WERE RETURNED SEPARATE AND NO ATTEMPT WAS MADE TO COMBINE THEM IN THE LAB. PROVIDED VIDEO SHOWS ATTEMPTED INSERTION OF BOTH LINERS INTO SHELL, LINERS DID NOT SEAT PROPERLY IN SHELL. THE VIDEO WAS NOT TAKEN DURING THE SURGERY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT 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). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED. ITEM # 010000801/ G7 HI-WALL ARCOMXL LNR/ LOT # 6617746. ITEM # 010000811/ G7 HI-WALL ARCOMXL LNR /LOT # 6744972. REPORT SOURCE FOREIGN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034 -2021 -01106. 0001825034 -2021 -01101.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE SURGEON WAS UNABLE TO INSERT THE POLYETHYLENE LINER INTO THE ACETABULAR CUP. THE SURGEON THEN TRIED A BACKUP LINER AND IT WAS ALSO UNSUCCESSFUL. THE G7 ACETABULAR CUP WAS REPLACED WITH A MALLORY HEAD ACETABULAR CUP. 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
    582435 G7 FINNED 4 HOLE SHELL 54F PROSTHESIS HIP OQI ZIMMER BIOMET, INC. NI 6746444 0088030452931

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR