BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH

    MDR report key: 19605528 · Received June 25, 2024

    Report

    Report Number
    0001822565-2024-02120
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    February 15, 2024
    Report Date
    August 30, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024119826
    PMA / PMN Number
    K934765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT #: 20103605 / 36MM I.D. SIZE E NEUTRAL LINER / LOT #: 65255952 UNKNOWN APICAL HOLE PLUG. CAT #: 010000663 / G7 PPS LTD ACET SHELL 52E / LOT #: 7205831. CAT #: 51-104130 / TPRLC 133 T1 PPS HO 13X146MM / LOT #: 7062049. CAT #: 650-0662 / DELTA CERAMIC FEM HD 36/+3MM / LOT #: 3095589. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2024-02119, 0001825034-2024-01679, 0001825034-2024-01680, 3002806535-2024-00235. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: MOBILITY ISSUES AND PAIN WITH TEMPORARY RELIEF DUE TO MEDICATION. AN MRI WAS PERFORMED AND THE PATIENT WAS CONFIRMED TO HAVE NO LOOSENING, INFECTION, MALALIGNMENT, OR SURROUNDING FLUID COLLECTION. THE COMPLAINT IS CONFIRMED BASED ON THE EVALUATION OF THE PROVIDED MEDICAL RECORDS. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. 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 DURING A CLINICAL STUDY, AT THE 2 YEAR FOLLOW-UP APPOINTMENT, THE PATIENT HAD BEEN EXPERIENCING GROIN PAIN THAT RADIATES TO THE LATERAL HIP FOR THE LAST THREE MONTHS. SO FAR, THE PATIENT HAS BEEN TREATED THROUGH PAIN MANAGEMENT CLINIC VISITS WITH NARCOTIC PAIN MEDICATION AND MULTIPLE UNKNOWN INJECTS THAT RESULTS IN TEMPORARY PAIN RELIEF. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481919 BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI J7180079 00889024119826

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11 NARRATIVE.