BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BISPHERICAL SHELL 50D

    MDR report key: 10453494 · Received August 26, 2020

    Report

    Report Number
    3002806535-2020-00378
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    May 5, 2017
    Report Date
    August 26, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A COMBINED INITIAL / FINAL MDR REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: GTS STANDARD FMRL STEM SIZE +3, CATALOG #: PS129GP3, LOT #: 1190394. EMAIL RECEIVED THAT NO FURTHER INFORMATION AVAILABLE. SUMMARY: 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 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 WITH THE ITEM AND LOT COMBINATION. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 1 SIMILAR COMPLAINTS REPORTED WITH THE ITEM 110017331. NOTHING CAN BE CONCLUDED FROM THIS AS REASON FOR REVISION IS UNKNOWN. 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 UNKNOWN REASON. 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. AT THIS TIME, NO RISK ASSESSMENT CAN BE CONDUCTED SINCE THE HARM OR REASON FOR REVISION HAS NOT BEEN BE REPORTED. IF FURTHER INFORMATION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT OR REASON FOR REVISION ARE PROVIDED, THE RISK WILL BE RE-ASSESSED. 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. PRODUCT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS NOTED A PATIENT UNDERWENT A PRIMARY PROCEDURE ON (B)(6) 2017. SUBSEQUENTLY, THAT PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2017 DUE TO UNKNOWN REASON WHERE STEM AND CUP WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919633 G7 BISPHERICAL SHELL 50D ACETABULAR SHELL LPH BIOMET UK LTD. N/A 3979320

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R