BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI ACETABULAR SHELL

    MDR report key: 24574438 · Received March 11, 2026

    Report

    Report Number
    0001825034-2026-00548
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    September 17, 2025
    Report Date
    March 11, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868355912
    PMA / PMN Number
    K140669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00877504002 LOT# 3243024 BIOLOX DELTA, CERAMIC FEMORAL HEAD. CAT# 00625006520 LOT# 67283893 BONE SCREW SELF-TAPPING. CAT# 00625006530 LOT# J7916823 BONE SCREW SELF-TAPPING. CAT# 30104007 LOT# 67377895 40MM I.D. SIZE G NEUTRAL LINER. CAT# 611201030 LOT# ZB2500620 Z1 STD COL CMTLESS SZ 3. 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 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST RIGHT HIP IMPLANTATION, THE PATIENT WAS TREATED WITH ANTIBIOTICS DUE TO ERYTHEMA AND FIBROUS EXUDATE AT THE INCISION SITE. THERE WAS NO CONFIRMED INFECTION. A COURSE OF ANTIBIOTICS WAS GIVEN OUT OF CAUTION. ISSUE WAS RESOLVED AT THE NEXT FOLLOW UP APPROXIMATELY ONE MONTH LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634435 G7 OSSEOTI ACETABULAR SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 67130424 00887868355912

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention