BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAN REINF RING SS 48/58MM

    MDR report key: 23905988 · Received December 29, 2025

    Report

    Report Number
    3002806535-2025-00676
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    October 16, 2018
    Report Date
    December 29, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024572706. D10: AVAN CMNTD SHELL SS 50MM; ITEM NUMBER# P0463050; LOT NUMBER# RA01207895, AVAN TAP CORT SCR SS 4.5X52MM; ITEM NUMBER# P0606052; LOT NUMBER# 0001071684, AVAN TAP CORT SCR SS 4.5X48MM; ITEM NUMBER# P0606048; LOT NUMBER# 0000975228, AVAN TAP CORT SCR SS 4.5X56MM; ITEM NUMBER# P0606056; LOT NUMBER# 0000891244, AVAN TAP CORT SCR SS 4.5X60MM; ITEM NUMBER# P0606060; LOT NUMBER# 0000911993, AVAN TAP CORT SCR SS 4.5X58MM; ITEM NUMBER# P0606058; LOT NUMBER# 0000910840, AVAN TAP CORT SCR SS 4.5X26MM; ITEM NUMBER# P0606026; LOT NUMBER# 0001082137, AVAN TAP CORT SCR SS 4.5X20MM; ITEM NUMBER# P0606020; LOT NUMBER# 0001064913, AVANTAGE INLAY S50 / 28; ITEM NUMBER# P0561050; LOT NUMBER# 0001197280, TAPERLOC STEM; ITEM NUMBER# 14-13200; LOT NUMBER# 604300, 28MM DIA COCR MOD HD -3MM NK; ITEM NUMBER# 163661; LOT NUMBER# 249660, MEDACTA KERBOUL CROSS; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN, HERMA ALLOGRAFT; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN, HERAEUS MEDICAL BONE CEMENT; ITEM NUMBER# 66022683; LOT NUMBER# 85944588, G2: FOREIGN - EVENT OCCURRED IN CANADA. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K190656 . 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 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1 YEAR, 3 MONTHS AND 2 DAYS POST IMPLANTATION DUE TO LOOSENING, PAIN, AND DIFFICULTIES WITH ADL¿S. DURING THE REVISION NOTED INFLAMMATION AND SCLEROTIC BONE. IT WAS ALSO NOTED THAT THE STEM HAS SOME DAMAGE TO THE TAPER BUT REMAINED IMPLANTED. THE ACETABULAR CONSTRUCT AND ALLOGRAFT, ZIMMER PLATE, SCREWS, CUP, BONE CEMENT AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083579 AVAN REINF RING SS 48/58MM HIP PROSTHESIS LZO BIOMET UK LTD. 0000950718

    Patients

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