BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS® FEMORAL HEAD 0X36MM DIA

    MDR report key: 20350290 · Received October 2, 2024

    Report

    Report Number
    0001822565-2024-03143
    Event Type
    Injury
    Date Received
    October 2, 2024
    Report Date
    January 22, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 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 HAS BEEN FILED UNDER MFR NUMBER 0002648920-2025-00017.

    Additional Manufacturer Narrative · 0

    (B)(). 00-7713-009-00 ITEM NAME MOD ML TAPER FEM ST 9.0 LOT # 60815980. 00-6200-052-22 ITEM NAME F/M ACET SHELL 52MMOD CLUSTER LOT # 60790214. 00-6305-050-36 ITEM NAME XLPE POLY LINER 50/52/54 X 36 LOT # 60741718. 00625006525 ITEM NAME BONE SCR 6.5X25 SELFTAP LOT # 60834380. 00625006525 ITEM NAME BONE SCR 6.5X25 SELFTAP LOT # 60834380. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    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 HAS BEEN FILED UNDER MFR NUMBER 0002648920-2025-00017.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 YEARS POST IMPLANTATION, THE PATIENT REPORTED MILD TO MODERATE PAIN AND AT THE 5 YEAR FOLLOW-UP, REPORTS MODERATE PAIN AND THE LEFT LEG BEING SHORTER. LATER, AT THE 10 YEAR FOLLOW-UP RADIOGRAPHIC IMAGING DISPLAYED A REACTIVE SCLEROTIC LINE. NO INTERVENTION HAS BEEN REPORTED AND ALL IMPLANTS REMAIN IN PLACE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352204 VERSYS® FEMORAL HEAD 0X36MM DIA PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 60829322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| H