BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4361007 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00068
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. A REVIEW OF SALES RECORDS IDENTIFIES NO FURTHER PROSTHESIS DISPATCHED FOR THIS PATIENT, THEREFORE IT IS NOT POSSIBLE TO IDENTIFY IF THE PATIENT HAS BEEN REVISED TO DATE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED EVENT. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR PROXIMAL FEMUR IMPLANT (K121056).

    Additional Manufacturer Narrative · 1

    A DESIGN PROPOSAL HAS BEEN PROVIDED TO THE SURGEON, HOWEVER IT IS UNKNOWN IF A REVISION SURGERY HAS TAKEN PLACE. BASED ON A STANMORE REVIEW OF THE PROVIDED INFORMATION, THE REPORTED SUBLUXATION WAS NOT CONFIRMED. AS THE DEVICE HAS NOT BEEN RETURNED IT IS NOT POSSIBLE TO ASSESS THE ACTUAL IMPLANT. NO INFORMATION RELATING TO THE PATIENTS ACTIVITY LEVELS IS AVAILABLE. A REVIEW OF THE BATCH RECORDS REVEALED NO EVIDENCE THAT NON-CONFORMING PRODUCTS WERE RELEASED FROM THIS BATCH. STANMORE HAS DETERMINED TO CLOSE THIS COMPLAINT FILE PENDING FURTHER FEEDBACK. A NEW FILE WILL BE OPENED IF THE CASE MOVES FORWARD. THIS COMPLAINT IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00068 (B)(4). IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE ON (B)(6) 2003 AND SUBSEQUENTLY REPORTS A SUBLUXATED HIP. IT IS UNKNOWN IF THE PATIENT HAS BEEN REVISED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE ON (B)(6) 2003 AND SUBSEQUENTLY REPORTS A SUBLUXATED HIP. IT IS UNKNOWN IF THE PATIENT HAS BEEN REVISED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837808 CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT PROXIMAL FEMUR IMPLANT JDI STANMORE IMPLANTS WORLDWIDE LTD BME10069

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention