BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 OSSEOTI MULTIHOLE 58MM G

    MDR report key: 15833023 · Received November 21, 2022

    Report

    Report Number
    0001825034-2022-02637
    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
    00887868356056
    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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS: MDR328146 AND MDR328147. 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 PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET. THE INVESTIGATION IS CURRENTLY IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE SHELL HAVING MINOR SCRATCHING AND DENTS ON THE INNER RADII. IT IS UNKNOWN IF THE DAMAGE OCCURRED PRIOR TO OR DURING THE ASSEMBLY ATTEMPTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LINERS 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.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384956 G7 OSSEOTI MULTIHOLE 58MM G PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 7075093 00887868356056

    Patients

    Seq Age Sex Outcome Treatment
    1 Female