BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 6.5 MM

    MDR report key: 20944162 · Received December 16, 2024

    Report

    Report Number
    0001822565-2024-03964
    Event Type
    Injury
    Date Received
    December 16, 2024
    Report Date
    April 16, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CMP (B)(4). D10: CAT #: 110010264 / G7 OSSEOTI MULTIHOLE 52MM E / LOT #: 6392037, CAT #: 010000857 / G7 NEUTRAL E1 LINER 36MM E / LOT #: 6500064, 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 #: 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; H2; H3; H11. THE FOLLOWING SECTION WAS CORRECTED: H11. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED, AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 2648920 PONCE.

    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

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED, AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 2648920 PONCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328215 BONE SCREW SELF-TAPPING 6.5 MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 64334917

    Patients

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