BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVON PAT/FEM JOINT SML

    MDR report key: 3753462 · Received April 16, 2014

    Report

    Report Number
    0002249697-2014-01250
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    January 1, 2010
    Report Date
    March 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRR
    PMA / PMN Number
    K052917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER RIGHT KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ITEM WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED. CAT. NO.: 6479-4-911, KX+ DURATION PATELLA MED, LOT CODE: LBE516. THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN INVOLVING AN AVON PATELLA-FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. THE DEVICE REMAINS IMPLANTED. MEDICAL RECORDS RECEIVED AND EVALUATION: MEDICAL REVIEW CONCLUDED THAT THERE IS NO DOCUMENTATION OF A RECALL OF THESE COMPONENTS. OTHER THAN THE FOLLOW-UP DESCRIPTION OF EXCELLENT RANGE OF MOTION, GOOD POSITIONING, AND ¿MILD PATELLA FEMORAL CREPITUS¿ THERE IS NO DOCUMENTED CONFIRMATION OF THE COMPLAINTS NOTED IN THE EVENT DESCRIPTION. THERE IS NO FOLLOW-UP SUBSEQUENT TO (B)(6) 2011 AND NO EVIDENCE OF FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS RESPONSIBLE FOR THIS CLINICAL SITUATION. DEVICE HISTORY REVIEW: DHR REVIEW WAS SATISFACTORY. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE REPORTED PAIN WAS CONFIRMED THROUGH THE MEDICAL RECORDS PROVIDED. THE MEDICAL REVIEW INDICATED THAT THE PATIENT HAD EXCELLENT RANGE OF MOTION AND THE COMPONENTS POSITION WAS GOOD. THERE IS NO EVIDENCE OF FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS RESPONSIBLE FOR THIS CLINICAL SITUATION. THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARS LOTS OF POPPING AND SCRATCHING SOUND LIKE METAL IN BOTH LEFT AND RIGHT KNEE. PATIENT ALSO HAS PAIN TIME TO TIME IN BOTH KNEES. HE IS CONCERNED IF HIS IMPLANT IS PART OF THE RECALL PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARS LOTS OF POPPING AND SCRATCHING SOUND LIKE METAL IN BOTH LEFT AND RIGHT KNEE. PATIENT ALSO HAS PAIN TIME TO TIME IN BOTH KNEES. HE IS CONCERNED IF HIS IMPLANT IS PART OF THE RECALL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233565 AVON PAT/FEM JOINT SML IMPLANT KRR STRYKER ORTHOPAEDICS-MAHWAH SPS4L

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other