BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BISPHERICAL SHELL 46B

    MDR report key: 22963242 · Received September 4, 2025

    Report

    Report Number
    3002806535-2025-00439
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 11, 2025
    Report Date
    February 2, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    05019279515660
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: UNKNOWN STEM TAPERLOC 6; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN. UNKNOWN DELTA CERAMIC HEAD S-32; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN. UNKNOWN E1-PE; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN. UNKNOWN SCREW; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN. G2- GERMANY. 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. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: NAME# DELTA CER FM HD 032/-4.0 12/14; ITEM NUMBER# 650-0833; LOT NUMBER# UNKNOWN. NAME# G7 NEUTRAL E1 LINER 32MM B; ITEM NUMBER# 010000846; LOT NUMBER# 3751712. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT INVOLVED IN THE REPORTED EVENT WAS RETURNED FOR INVESTIGATION, AND PRODUCT IDENTIFICATION WAS CONFIRMED. THE SHELL WAS RETURNED WITH THE LINER STILL ASSEMBLED. THE APICAL PLUG AND ALL THREE SCREW-HOLE PLUGS WERE PRESENT IN THE SHELL; HOWEVER, DUE TO THE LINER ASSEMBLY, NO ETCH MARKINGS WERE VISIBLE ON THE PLUGS. NICKS AND SCRATCHES WERE OBSERVED ON THE TOP FLAT SURFACE OF THE SHELL, AND MULTIPLE NICKS WERE NOTED ON THE OUTER DIAMETER (O.D.) TEETH. NO ADDITIONAL DAMAGE WAS IDENTIFIED DURING THE VISUAL EVALUATION. THE DEVICE HAD BEEN IMPLANTED FOR APPROXIMATELY SEVEN YEARS. THERE IS NO DEMONSTRABLE EVIDENCE OF BONE ADHERENCE, WHICH WOULD ORDINARILY BE EXPECTED AFTER 7 YEARS OF IMPLANTATION. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED. THE REVIEW IDENTIFIED ASEPTIC LOOSENING OF THE CEMENTLESS RIGHT HIP WITH NO EVIDENCE OF BONE INTEGRATION. THERE WERE NO SIGNS OF INFECTION. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA. ABUNDANT SCAR TISSUE WAS RESECTED, AND THE SHELL WAS FOUND TO BE COMPLETELY LOOSE. CANCELLOUS BONE CHIPS WERE PLACED. A 20 MM INSPECTION PAN (ZIMMER) WAS IMPACTED; HOWEVER, IT WAS DETERMINED TO BE INSUFFICIENTLY DEEP. THE PAN WAS REMOVED, SLIGHTLY REPOSITIONED WITHIN THE CANCELLOUS BED, AND RESHAPED USING A TILLER, ACHIEVING GOOD STABILITY. INTRAOPERATIVE RADIOGRAPHS CONFIRMED APPROPRIATE POSITIONING. THE WOUND WAS IRRIGATED, AND THE SKIN WAS CLOSED IN LAYERS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 THE PATIENT UNDERWENT TO HIP REVISION SURGERY DUE TO ASEPTIC LOOSENING. DURING THE REVISION ABUNDANT SCAR TISSUE WAS NOTED AS WELL AS THE SHELL WAS COMPLETELY LOOSE. THE STEM WAS RETAINED ALL OTHER COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332301 G7 BISPHERICAL SHELL 46B PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. 6187749 05019279515660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE.