BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZB 12/14 COCR HD 32MM X +0

    MDR report key: 19006038 · Received March 29, 2024

    Report

    Report Number
    0001822565-2024-01081
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    March 6, 2024
    Report Date
    June 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024498839
    PMA / PMN Number
    K183457
    Removal / Correction Number
    N/A
    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). CONCOMITANT MEDICAL PRODUCTS: 4265 ALLOFIT-S ALLOCLAS SHELL 52/II 3065418. 01.00013.509 DURAL ALPHA INSERT W RIM II/32 3060690. G2: REPORT SOURCE: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 AND/OR CORRECTED INFORMATION. PROPOSED COMPONENT CODE: MECHANICAL (G04)- HEAD. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE CONSTRUCT STILL ASSEMBLED AFTER EXPLANT, AND THEN SUBSEQUENTLY SEPARATED. THE DEVICES ARE COVERED IN BIO-DEBRIS. NO FURTHER EVALUATION CAN 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: ANATOMIC ALIGNMENT OF THE LEFT HIP ARTHROPLASTY WITHOUT DISLOCATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IMPLANT PLACEMENT IS THE SURGEON'S DISCRETION. THIS COMPLAINT CANNOT BE CONFIRMED. 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 THE PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ONE YEAR POST IMPLANTATION DUE TO DISLOCATION DUE TO PLACEMENT OF THE ACETABULAR COMPONENT. THE HEAD, LINER, AND SHELL WERE EXCHANGED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2589428 ZB 12/14 COCR HD 32MM X +0 PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 3047396 00889024498839

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R