BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/0MM

    MDR report key: 17763533 · Received September 18, 2023

    Report

    Report Number
    3002806535-2023-00308
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    September 4, 2019
    Report Date
    December 14, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    05019279085941
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT MEDICAL PRODUCTS: TPRLC 133 TYPE1 BM SO 14.0; ITEM# 51-113140; LOT# 6057581. G7 10 DEG E1 LINER 36MM G; ITEM# 010000898; LOT# 3959772. G7 BONEMASTER LTD ACET SHL 60G; ITEM# 010000707; LOT# 6332149. G2 - REPORT SOURCE: AUSTRALIA. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. OTHER THAN THE REMOVAL OF EXTENSIVE SCAR TISSUE THERE WERE NO NOTABLE INTRAOPERATIVE EVENTS OR COMPLICATIONS. THE POLYETHYLENE LINER WAS INTACT AND NOT REVISED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED DISLOCATION/SUBLUXATION OF THE RIGHT HIP ARTHROPLASTY. THERE IS NO ABNORMAL RADIOLUCENCY OR EVIDENCE OF IMPLANT LOOSENING. WITH THE AVAILABLE INFORMATION, 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 A PATIENT UNDERWENT A REVISION SURGERY SEVEN MONTHS POST IMPLANTATION DUE TO PAIN, POSSIBLE POLY DISIMPACTION, AND INSTABILITY. DURING THE SURGERY, THE POLY WAS FOUND INTACT AND EXTENSIVE SCAR TISSUE WAS DEBRIDED. ONLY THE HEAD WAS REVISED AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. 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
    289909 DELTA CERAMIC FEM HD 36/0MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO BIOMET UK LTD. 2018052312 05019279085941

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H