BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER MODULAR FEMORAL STEM

    MDR report key: 2003815 · Received February 24, 2011

    Report

    Report Number
    1822565-2011-00396
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SEVERAL X-RAYS AND SURGICAL NOTES FROM THE PRIMARY SURGERY WERE PROVIDED. NO COMPLICATIONS WERE REPORTED IN THE SURGICAL NOTES. THE FIT AND ORIENTATION OF THE IMPLANTS APPEAR TO BE NORMAL IN THE POST-OP X-RAYS FROM THE PRIMARY SURGERY. A SUBSEQUENT X-RAY FROM (B)(6) 2011 APPEARS TO SHOW THAT AT LEAST SOME OF THE COMPONENTS WERE REVISED, BUT THIS INFORMATION CANNOT BE CONFIRMED. THE CONDITION OF THE DEVICES IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT FOLLOWED THE PROPER REHABILITATION PROTOCOLS. A DEFINITIVE CAUSE FOR THIS ISSUE CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS PRESENTING WITH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER MODULAR FEMORAL STEM LPH ZIMMER, INC. 60739166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT# 60674414| KINECTIV MODULAR NECK: CATALOG # 00784802300,