BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 36MM E

    MDR report key: 20939944 · Received December 16, 2024

    Report

    Report Number
    0001825034-2024-02955
    Event Type
    Injury
    Date Received
    December 16, 2024
    Report Date
    April 9, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT #: 110010264 / G7 OSSEOTI MULTIHOLE 52MM E / LOT #: 6392037 CAT #: 51-108080 / TPRLC 133 MP T1 PPS SO 8X101MM / LOT #: 6490058 CAT #: 00625006530 / BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH / LOT #: 64334917 CAT #: 00625006530 / BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH / LOT #: 64334916 CAT #: 650-1057 / CER BIOLOXD OPTION HD 36MM / LOT #: 2952466 CAT #: 650-1066 / CER OPT TYPE 1 TPR SLEVE 0MM / LOT #: 2952466. 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 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: D4; G3; H2; H3; H4; H6; H10. THE FOLLOWING SECTIONS WERE CORRECTED: B3. B3: EVENT DATE: JAN-2021. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS AND X-RAYS WERE PROVIDED AND IDENTIFIED THE FOLLOWING: PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH COMPLAINT OF MEDIAL LEFT LEG PARAESTHESIA SINCE INITIAL SURGERY AMD A SERIES OF FOLLOW-UPS REPORTED INCREASED PAIN IN LEFT HIP. PATIENT PRESENTED WITH POST OPERATIVE QUADRICEPS NERVE PALSY AND WAS RECOMMENDED TO SEE NEUROSURGEON FOR NERVE TRANSPLANT. PATIENT REPORTED THEY HAD A FEMORAL NERVE REPAIR DUE TO NERVE PALSY BECAUSE OF A NERVE LESION DURING THE LEFT THA. FOLLOWING, PATIENT REPORTS NO PAIN AND AMBULATES WITH NORMAL GAIT WITHOUT ASSISTIVE DEVICES. XRAY SHOWS IMPLANT IN GOOD POSITION, NO EVIDENCE OF LYSIS, FRACTURE, BEARING WEAR, OR SUBSIDENCE. NO DEVICES WERE EXPLANTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, THE SURGICAL TECHNIQUE IS THOUGHT TO BE A POTENTIAL FACTOR THAT COULD HAVE CONTRIBUTED TO THE NERVE LESION. AS PER IFU 01-50-1231 AND IFU 01-50-0909 UNDER RISKS IT STATES 'WHILE COMPLICATIONS VARY DEPENDING ON THE TYPE OF ORTHOPAEDIC SURGERY AND WHILE MITIGATIONS ARE IMPLEMENTED TO REDUCE THESE RISKS AS FAR AS POSSIBLE, SOME RESIDUAL RISKS, ASSOCIATED WITH THE SYSTEM, INCLUDING ITS COMPONENTS, CAN ARISE DURING AND FOLLOWING SURGERY INCLUDE; PAIN OR ACHE, TISSUE DAMAGE. BASED ON THE PROVIDED INFORMATION, THE COMPLAINT CANNOT BE CONFIRMED. 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 A PATIENT UNDERWENT A LEFT FEMORAL NERVE REPAIR DUE TO A NERVE LESION APPROXIMATELY A YEAR AND EIGHT MONTHS POST IMPLANTATION. ALL OF THE IMPLANTS REMAIN IN PLACE AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356126 G7 NEUTRAL E1 LINER 36MM E PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. NI 6500064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 NARRATIVE