BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 VIT E 10DEG LNR 36MM G

    MDR report key: 15225545 · Received August 15, 2022

    Report

    Report Number
    0001822565-2022-02370
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 22, 2022
    Report Date
    October 18, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024520219
    PMA / PMN Number
    K190660
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS:¿ 110010248- G7 OSSEOTI 4 HOLE SHELL 60MM G- 65300689; 192414- ECHO POR FMRL RED NC 14X150MM- 379810; 650-0663- DELTA CERAMIC FEM HD 36/+6MM- 3076984; 010000997- G7 SCREW 6.5MM X 20MM- 7070374; 010000998- G7 SCREW 6.5MM X 25MM- 7134899. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED NICKS AND GOUGES TO THE INNER AND OUTER SPHERICAL SURFACES, FACE, ANTI-ROTATION SCALLOPS, AND LOCKING FEATURE FROM ATTEMPTED IMPLANTATION. NO OTHER DAMAGE WAS NOTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED LINER WOULD NOT SEAT CUP. THE CUP WAS DRIED; SCREWS WERE CHECKED TO ENSURE THEY WERE DOWN THE ENTIRE WAY. EVENTUALLY A NEW 10-DEGREE LINER WAS OFFERED AND IT IMMEDIATELY SEATED CORRECTLY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252447 G7 VIT E 10DEG LNR 36MM G PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64643459 00889024520219

    Patients

    Seq Age Sex Outcome Treatment
    1 Male