BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BISPHERICAL SHELL 50D

    MDR report key: 21908692 · Received April 25, 2025

    Report

    Report Number
    3002806535-2025-00171
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    October 7, 2019
    Report Date
    September 19, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    05019279515684
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, D1, D4, D6, D8, D10, G3, G6, H2, H4, H11. D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: G7 NEUTRAL E1 LINER 36MM D; ITEM# 010000856; LOT# 6588485 TPRLC 133 FP 12/14 PPS HO 11.0; ITEM# 51-121110; LOT# 6536860 DELTA CER FM HD 036/-4MM 12/14; ITEM# 650-0836; LOT# 2019060631 G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K101336. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D4 - THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE LOT NUMBER OF THE DEVICE IS CURRENTLY UNKNOWN. G2 - FOREIGN: GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A 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: B4, B5, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS CONFIRMED THAT THIS ITEM IS INCLUDED WITHIN THE SCOPE OF A CAPA, PRODUCT HOLD AND FIELD ACTION. WITH THE AVAILABLE INFORMATION HOWEVER, IT CANNOT BE ESTABLISHED THAT THIS COMPLAINT IS IN RELATION TO THE SAME ISSUE FOR WHICH THE ACTIONS WERE PREVIOUSLY INITIATED AS ABOVE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER IMPLANTATION, THE PATIENT UNDERWENT AN UNKNOWN TREATMENT DUE TO UNKNOWN REASONS. DUE DILIGENCE IS STILL IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER IMPLANTATION, THE PATIENT UNDERWENT AN UNKNOWN TREATMENT DUE TO UNKNOWN REASONS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227526 G7 BISPHERICAL SHELL 50D HIP PROSTHESIS LZO BIOMET UK LTD. 6596904 05019279515684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11 NARRATIVE.