BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 3 HOLE SHELL 52MM E

    MDR report key: 16983062 · Received May 23, 2023

    Report

    Report Number
    0001825034-2023-01159
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    March 10, 2021
    Report Date
    June 8, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304544192
    PMA / PMN Number
    K140669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01160, 0001825034-2023-01161. D10: CAT #: 010000935 / G7 HI-WALL E1 LINER 36MM E / LOT #: 6374859. CAT #: 193111 / ECHO B-MTRC MP FP HO 11 / LOT #: 163920. CAT #: 12-115121 / CER BIOLOXD MOD HD 36MM STD NK / LOT #: 2971283. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: B4; B5; D4; G3; H2; H3; H4; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE COMPLAINT IS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. ROOT CAUSE WAS UNABLE TO 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 A PATIENT DEVELOPED SEVERE PAIN REQUIRING MEDICATION APPROXIMATELY TWO YEARS POST IMPLANTATION. UPON RECEIPT OF THE MEDICATION, THE ISSUE WAS RESOLVED APPROXIMATELY ONE MONTH LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    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
    183287 G7 OSSEOTI 3 HOLE SHELL 52MM E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 6424109 00880304544192

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention| H SEE H10