BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MGRM KNEE BALANCER HEIGHT GDE

    MDR report key: 3033613 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01187
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED. DEVICE HISTORY REVIEW: THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT.

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. NO DEVICE EVALUATION PERFORMED AS NO ITEMS WERE RETURNED AS THE DEVICE WAS DISCARDED. NO MEDICAL RECORDS EVALUATION PERFORMED AS NO ADVERSE CONSEQUENCES WERE REPORTED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS EXAMINATION OF THE BROKEN DEVICE IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. THE REPORTED EVENT REGARDING A FRACTURE INTRA-OPERATIVELY OF A MONOGRAM KNEE BALANCER HEIGHT GUIDE INSTRUMENT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A TOTAL KNEE REPLACEMENT AND DURING THE SURGERY THE INSTRUMENT CRACKED A PIECE BROKE OFF OF THE MONOGRAM KNEE BALANCER HEIGHT GUIDE. COULD NO LONGER USE IN SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A TOTAL KNEE REPLACEMENT AND DURING THE SURGERY THE INSTRUMENT CRACKED A PIECE BROKE OFF OF THE MONOGRAM KNEE BALANCER HEIGHT GUIDE. COULD NO LONGER USE IN SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A TOTAL KNEE REPLACEMENT AND DURING THE SURGERY, THE INSTRUMENT CRACKED A PIECE BROKE OFF OF THE MONOGRAM KNEE BALANCER HEIGHT GUIDE. COULD NO LONGER USE IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136990 MGRM KNEE BALANCER HEIGHT GDE INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH SLEB436D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other