BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI ACETABULAR SHELL

    MDR report key: 19116682 · Received April 16, 2024

    Report

    Report Number
    0001825034-2024-00328
    Event Type
    Injury
    Date Received
    April 16, 2024
    Report Date
    April 16, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304544222
    PMA / PMN Number
    K140669
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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: 0001825034-2024-00329. D10: ITEM# 51-103140; LOT# 6626648. ITEM# 650-1057; LOT# 2958797. ITEM# 650-1068; LOT# 2965056. ITEM# 30103607; LOT# 64358597. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ACETABULI PROTRUSIO OF THE ACETABULAR COMPONENT WITH SUBSIDENCE OF THE FEMORAL COMPONENT AND DISLOCATION OF THE FEMORAL HEAD. FRACTURE SUPEROMEDIAL AND ANTERIOR ACETABULUM. 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 BY THE PMI GROUP THAT A PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY FOR AN UNKNOWN REASON. X-RAYS RECEIVED AND REVIEWED, NOTING LOOSENING OF THE ACETABULAR COMPONENT, SUBSIDENCE OF THE FEMORAL COMPONENT, DISLOCATION OF THE FEMORAL HEAD, AND BONE FRACTURE OF THE ACETABULUM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125896 G7 OSSEOTI ACETABULAR SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER LPH ZIMMER BIOMET, INC. NI 6630992 00880304544222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other