BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 28/-3MM T1

    MDR report key: 9791467 · Received March 5, 2020

    Report

    Report Number
    3002806535-2020-00115
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    January 10, 2020
    Report Date
    August 28, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    K131684
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE PRODUCT EVALUATION COMPLAINTS ENGINEER FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Additional Manufacturer Narrative · 0

    (B)(6). THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7 D10, H1, H2, H10. IN ERROR, IT WAS STATED IN THE NARRATIVE THAT THE PRODUCT HAD BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION. PLEASE NOTE THAT THE PRODUCT HAS NOT BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION. SEE AMENDED NARRATIVE BELOW: AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BIPOLAR HIP ARTHROPLASTY, THE SURGEON WAS NOT SATISFIED WITH THE MOVEMENT OF THE CERAMIC HEAD WITHIN THE ACETABULAR CUP. SUBSEQUENTLY, THE CUP WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 0-15 MINUTES, IN ORDER TO PREPARE THE NEW PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BIPOLAR HIP ARTHROPLASTY, THE SURGEON WAS NOT SATISFIED WITH THE MOVEMENT OF THE CERAMIC HEAD WITHIN THE ACETABULAR CUP. SUBSEQUENTLY, THE CUP WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 0-15 MINUTES, IN ORDER TO PREPARE THE NEW PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCT: E1 RINGLOC BIPOLAR 28X42MM, CATALOG #: 110010464, LOT #: 669490; E1 RINGLOC BIPOLAR 28X42MM, CATALOG #: 110010464, LOT #: 669490. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BIPOLAR HIP ARTHROPLASTY, THE SURGEON WAS NOT SATISFIED WITH THE MOVEMENT OF THE CERAMIC HEAD WITHIN THE ACETABULAR CUP. SUBSEQUENTLY, THE CUP WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 0-15 MINUTES, IN ORDER TO PREPARE THE NEW PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255922 DELTA CER FEM HD 28/-3MM T1 CERAMIC FEMORAL HEAD PROSTHESIS LPH BIOMET UK LTD. N/A 2019071711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other