BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 10200131 · Received June 26, 2020

    Report

    Report Number
    3002806535-2020-00294
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    March 23, 2020
    Report Date
    July 30, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    UDI-DI
    00880304521919
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM 650-1065. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: 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. THE REPORTED EVENT STATES REVISION 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. THEREFORE, THE OUTCOME OF THE REPORTED EVENT (SURGICAL INTERVENTION) IS IN LINE WITH THE RMF. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY 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 THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE ACTIVE ARTICULATION BEARING AND CERAMIC HEAD WERE REMOVED AND REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: ACT ARTIC E1 HIP BRG 28X46MM, CATALOG #: EP-200152, LOT #: 831320; HIP-TAPERLOC-STEMS-UNK, CATALOG #: UNKNOWN, LOT #: 6545918; HIP-MAGNUM- CUP-UNK, CATALOG #: UNKNOWN, LOT #: 088000. 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 THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE ACTIVE ARTICULATION BEARING AND CERAMIC HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664582 CER BIOLOXD OPTION HD 28MM FEMORAL HEAD/STEM PROSTHESIS ADAPTOR LPH BIOMET UK LTD. N/A 2958709 00880304521919

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R