BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER -3.5 NECK LENGTH

    MDR report key: 21772899 · Received April 4, 2025

    Report

    Report Number
    0001822565-2025-00891
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 29, 2025
    Report Date
    May 1, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024498778
    PMA / PMN Number
    K183457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SUGGESTED COMPONENT CODE: MECHANICAL (G04) - HEAD. D10: CAT#: EP-200148, LOT#: 66202329 ACT ARTIC E1 HIP BRG 28X42MM. CAT#: 00833408402, LOT#: 65430489 CEMENT PRESSURIZER MEDIUM. CAT#: P0463048, LOT#: 0001799214 AVAN CMNTD SHELL SS 48MM. CAT#: 42.19.40, LOT#: 9999999999 COUNTERSUNK CANCELL SCR 6.5/40. CAT#: 42.19.30, LOT#: 9999999999 COUNTERSUNK CANCELL SCR 6.5/30. CAT#: 01.00191.250, LOT#: 3002257 B-S REINFORCMNT RING NEW 50 RT. CAT#: 00811400110, LOT#: 66348502 FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 1 130 MM STEM LENGTH. CAT#: 00801102024, LOT#: 66352085 ALLEN MEDULLARY CEMENT PLUGS 1-24 MM DIAMETER FLANGE/12 MM DIAMETER CORE STORE IN COOL DRY PLACE. G2: FOREIGN: AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: D4; G3; H2; H3; H4; H6. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THE EXPLANTED IMPLANTS BUT COULD NOT BE USED TO CONFIRM THE COMPLAINT. DEVICE NOT RETURNED, FURTHER ANALYSIS CANNOT BE MADE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A SINGLE UNDATED IMAGE REVIEWED AND NOT SUBMITTED TO MMI DUE TO THE INABILITY TO CORRELATE THE IMAGE WITH THE ALLEGATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. 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 THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR LATER DUE TO DISSOCIATION. THE HEAD AND BEARING DISASSOCIATED AND WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744203 FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER -3.5 NECK LENGTH PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 3172598 00889024498778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H