BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD MOD HD 28MM STD NK

    MDR report key: 16270061 · Received January 31, 2023

    Report

    Report Number
    3002806535-2023-00030
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    January 5, 2023
    Report Date
    March 9, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868248412
    PMA / PMN Number
    K042091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - ACT ARTIC E1 HIP BRG 28X44MM, ITEM# EP-200150, LOT# 530940; M2A-MAGNUM PF CUP 50ODX44ID, ITEM# US157850, LOT# 249530; ECHO B-MTRC MP FP SO 9, ITEM# 193009, LOT# 681140. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SCUFFS AND SCRATCHES IN TAPER AND ON THE OUTER PARTS OF CERAMIC HEAD. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: PATIENT UNDERWENT HIP REVISION SURGERY DUE TO THE DISLOCATION ABOUT THREE (3) YEARS AFTER INITIAL SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104527 CER BIOLOXD MOD HD 28MM STD NK HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2983168 00887868248412

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE.