BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/0MM

    MDR report key: 9846748 · Received March 18, 2020

    Report

    Report Number
    3002806535-2020-00157
    Event Type
    Injury
    Date Received
    March 18, 2020
    Report Date
    May 21, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN DENMARK. D11: MEDICAL PRODUCT: RINGLOC-X ARCOMXL H/W 56/36MM, CATALOG #: XL-053656, LOT #: 3312527. MEDICAL PRODUCT: SIRIUS HIP STEM 44-F, CATALOG #: 51-199343, LOT #: 551390. MEDICAL PRODUCT: EXC ABT RNGLC-X SHELL PC 056MM, CATALOG #: 131356, LOT #: 3457092. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00158-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 3 SIMILAR COMPLAINTS REPORTED WITH THE ITEM 650-0661 AND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM XL-053656. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: THE EVENT REPORTS REDUCTION DUE TO DISLOCATION. RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. HOWEVER, THE REPORTED EVENT STATES REDUCTION DUE TO DISLOCATION. IN THE RISK FILE, DISLOCATION IS CONSIDERED HARM WITH A SEVERITY LEVEL OF 3 FOR A NUMBER OF HAZARDS DEFINED AS MODERATE, WHICH IS DESCRIBED IN THE SEVERITY TABLE AS: S-3 PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THE OUTCOME OF THE REPORTED EVENT (MEDICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. THE EVENT REPORTS REDUCTION DUE TO DISLOCATION. IN ORDER TO CALCULATE THE OCCURRENCE RATE, SALES AND COMPLAINT DATA FOR THIS ITEM NUMBER HAVE BEEN OBTAINED, AND ARE ATTACHED FOR A PERIOD OF THE LAST 3 YEARS PRIOR TO THE NOTIFICATION DATE, BEING FEB 2020. SALES (FEB 2017 TO FEB 2020) = (B)(4) UNITS. COMPLAINTS SEARCH WAS CONDUCTED FOR EVENTS OCCURRING BETWEEN FEB 2017 TO FEB 2020 FOR ITEM 650-0661. 4 COMPLAINTS WERE IDENTIFIED FOR THIS ITEM NUMBER INCLUDING (B)(4). 2 OF THE 4 COMPLAINTS WERE SAME PATIENT, AND 3 OF THE 4 COMPLAINTS WERE THE SAME DOCTOR. THEREFORE, THE CALCULATED OCCURRENCE RATE IS 4 IN 17309 OR (B)(4). THE HIGHEST OCCURRENCE SCORE ASSOCIATED WITH THE HARM OF DISLOCATION IS 2 REMOTE: (B)(4) - (B)(4)). MULTIPLE HAZARDS AND HAZARDOUS SITUATIONS RESULT IN A HARM OF DISLOCATION. THE ROOT CAUSE OF THE ABOVE COMPLAINT HAS NOT BEEN DETERMINED, THEREFORE A SPECIFIC HAZARD CANNOT BE SELECTED. AS A HAZARD CANNOT BE SELECTED, THE OCCURRENCE SCORE FOR ONE HAZARD CANNOT BE ATTRIBUTED TO ALL EVENTS, AND THEREFORE CANNOT BE USED FOR COMPARISON. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED AT THIS TIME. 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 A PATIENT UNDERWENT AN INITIAL LEFT HIP PROCEDURE. SUBSEQUENTLY, A REDUCTION PROCEDURE WAS PERFORMED DUE TO DISLOCATION. THE INCIDENT HAPPENED IN GREENLAND ON AN UNKNOWN DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT REMAINS IMPLANTED. MEDICAL PRODUCT RINGLOC-X ARCOMXL H/W 56/36MM:, CATALOG #:XL-053656, LOT #: 3312527. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2020-00158. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT HIP PROCEDURE. SUBSEQUENTLY, PATIENT EXPERIENCED A DISLOCATION OF THE HIP. REDUCTION CARRIED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312577 DELTA CERAMIC FEM HD 36/0MM HIP PROTHESIS LPH BIOMET UK LTD. N/A 3456171

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R