BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/0MM

    MDR report key: 10238283 · Received July 7, 2020

    Report

    Report Number
    3002806535-2020-00310
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 29, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    K131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN JAPAN. D11: MEDICAL PRODUCT: TPRLC 133 FP TYPE1 PPS HO 7.0, CATALOG #: 51-101070, LOT #: 6041877. MEDICAL PRODUCT: LINER AND SHELL WITH PLASTIC BARRIER 36 MM I.D. 46 MM, CATALOG #: 00151504636, LOT #: 64014059. NO FURTHER INFORMATION AVAILABLE. 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 2 SIMILAR COMPLAINTS REPORTED WITH THE ITEM 650-0661. THE STERILISATION CERTIFICATES WERE REVIEWED AND CONFIRMED THAT PRODUCT IS STERILISED WITHIN THE SPECIFICATION RANGE. NO TRENDS WERE IDENTIFIED FROM COMPLAINT HISTORY REVIEW. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: THE EVENT REPORTS REVISION DUE TO INFECTION. 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 TABLE COULD NOT BE SELECTED FOR COMPARISON. INFECTION IS DOCUMENTED AS A POTENTIAL HARM AS AN OUTCOME OF A NUMBER OF HAZARDS ASSESSED BY THE REFERENCED RMF. INFECTION IS CONSIDERED A SEVERITY 3: MODERATE, WHICH AS PER THE SEVERITY TABLE LISTED WITHIN THE RMR IS DEFINED AS 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 THIS COMPLAINT (SURGICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A THA SURGERY ON (B)(6) 2020 AND DEVELOPED AN INFECTION. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: TPRLC 133 FP TYPE1 PPS HO 7.0, CATALOG #: 51-101070, LOT #: 6041877. LINER AND SHELL WITH PLASTIC BARRIER 36 MM I.D. 46 MM, CATALOG #:00151504636, LOT #: 64014059. (B)(6). 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 PATIENT UNDERWENT A THA SURGERY ON (B)(6) 2020 AND DEVELOPED AN INFECTION. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704349 DELTA CERAMIC FEM HD 36/0MM CERAMIC FEMORAL HEAD PROSTHESIS LPH BIOMET UK LTD. N/A 2019020332

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R