BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BISPHERICAL SHELL 52E

    MDR report key: 21750152 · Received April 2, 2025

    Report

    Report Number
    3002806535-2025-00142
    Event Type
    Injury
    Date Received
    April 2, 2025
    Report Date
    June 17, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    EXEMPT
    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 - PRIMARY DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN. LOT NUMBER GIVEN IN THE USER REPORT 09110/25 (LOT 684908) IS NOT COMPLETE AND IS MISSING ONE DIGIT. D4 - THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00880304449442. D-10: UNKNOWN LINER, LOT UNKNOWN; UNKNOWN HEAD, LOT UNKNOWN. G2 ¿ FOREIGN ¿ 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. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H11 - ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. DUE TO INSUFFICIENT PRODUCT INFORMATION ON THE CONCOMITANT PRODUCTS, THE COMPATIBILITY OF THE INVOLVED PRODUCTS COULD NOT BE VERIFIED. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM. HOWEVER, DUE TO THE LACK OF THE LOT NUMBER, AN ADDITIONAL LOT SEARCH COULD NOT BE PERFORMED. ANY PATIENT AND SURGICAL RELATED FACTORS REMAIN UNKNOWN, THEREFORE BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED, AND 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 A REVISION SURGERY FOUR YEARS POST IMPLANTATION DUE TO PAIN AND CUP LOOSENING. THERE WAS NO SIGN OF INFECTION. 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687898 G7 BISPHERICAL SHELL 52E HIP PROTHESIS LPH BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention| H SEE H11 NARRATIVE.