BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 FRDM CONST E1 10DEG LNR 36G

    MDR report key: 15833012 · Received November 21, 2022

    Report

    Report Number
    0001825034-2022-02635
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    November 7, 2022
    Report Date
    February 14, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304544598
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED BOTH OF THE LINERS HAD DAMAGE TO THE LOCKING FEATURE. LINER WITH LOT J7014710 (7042419) ALSO HAD AN INDENTATION TO THE OD OF THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE IMAGE PROVIDED WAS OF THE FINAL IMPLANTED PRODUCTS. THEY DID NOT ENHANCE THE INVESTIGATION AS THE REPORTED ISSUE WAS TO DO WITH THE RETURNED COMPONENTS. 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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MDR328147 AND MDR328148. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00625006525, ITEM NAME: BONE SCR 6.5X25 SELF-TAP, LOT # J7222341, ITEM NUMBER: 31-323230 ITEM NAME: 3.2MMX30MM RNGLC+ ACET DRL BIT, LOT # 731380, ITEM NUMBER: 00625006520 ITEM NAME: BONE SCR 6.5X20 SELF-TAP, LOT #J7278081, ITEM NUMBER: 00625006530 ITEM NAME: BONE SCR 6.5X30 SELF-TAP, LOT # J7007847, ITEM NUMBER: 00625006540 ITEM NAME: BONE SCR 6.5X40 SELF-TAP, LOT # J7332696, ITEM NUMBER: 110010269 ITEM NAME: G7 OSSEOTI MULTIHOLE 62MM H, LOT #6902757, ITEM NUMBER: 802403606 ITEM NAME: ZB 12/14 COCR FRDM 36MM X +9, LOT # 3062343, ITEM NUMBER: 00625006515 ITEM NAME: BONE SCR 6.5X15 SELF-TAP, LOT # J6867004, ITEM NUMBER: 00625006515 ITEM NAME: BONE SCR 6.5X15 SELF-TAP, LOT # J6993494, ITEM NUMBER: 00625006530 ITEM NAME: BONE SCR 6.5X30 SELF-TAP, LOT # J6960420, ITEM NUMBER: 30253608 ITEM NAME: G7 VIT E FRDM CONST +5MM 36H, LOT # 65330653. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PREVIOUS EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LINER WOULD NOT SEAT IN THE OSSEOTI SHELL. A NEW SHELL WAS REQUIRED TO COMPLETE THE PROCEDURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384945 G7 FRDM CONST E1 10DEG LNR 36G PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 7042419 00880304544598

    Patients

    Seq Age Sex Outcome Treatment
    1 Female