BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/-3MM

    MDR report key: 9303516 · Received November 11, 2019

    Report

    Report Number
    3002806535-2019-00849
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    September 17, 2019
    Report Date
    February 21, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. G3: REPORT SOURCE, FOREIGN: EVENT OCCURRED IN AUSTRALIA. D11: MEDICAL PRODUCT: EPOLY RLC 36MM 10DEG SZ24, CATALOG#: EP-105894, LOT#: 587250. MEDICAL PRODUCT: TPRLC 133 TYPE1 BM SO 12.0, CATALOG #: 51-113120, LOT#: 3472129. MEDICAL PRODUCT: MH SOLID SHELL HA/PC 54MM LN24, CATALOG#: 131154, LOT#: 3514262. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. REGULATORY ASSESSMENT DETERMINES THAT THE OCCURENCE OF THE EVENT AND THE RISK REMAINS WITHIN THE ACCEPTABLE LIMITS IDENTIFIED IN THE RISK MANAGEMENT REPORT. A REVIEW OF THE COMPLAINT DATABASE HAS FOUND 2 SIMILAR COMPLAINTS FOR THIS ITEM CODE: 650-0660. THERE WERE NO TRENDS IDENTIFIED FROM THE COMPLAINT HISTORY REVIEW. NO SAME LOT NUMBERS, NO SAME HOSPITALS AND THERE ARE NO TRENDS IN CAUSE. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 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 ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE LINER AND HEAD WAS REVISED TO A CONSTRAINED FREEDOM LINER/HEAD DUE TO HIP DISLOCATING.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: EPOLY RLC 36MM 10DEG SZ24 CATALOG #: EP-105894 LOT #: 587250, MEDICAL PRODUCT: TPRLC 133 TYPE1 BM SO 12.0 CATALOG #: 51-113120 LOT #: 3472129, MEDICAL PRODUCT: MH SOLID SHELL HA/PC 54MM LN24 CATALOG #: 131154 LOT #: 3514262. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE LINER AND HEAD WAS REVISED TO A CONSTRAINED FREEDOM LINER/HEAD DUE TO HIP DISLOCATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097884 DELTA CERAMIC FEM HD 36/-3MM HIP PROSTHESIS JDI BIOMET UK LTD. N/A 3509978

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R