BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT

    MDR report key: 6978913 · Received October 25, 2017

    Report

    Report Number
    3004154314-2017-00023
    Event Type
    Injury
    Date Received
    October 25, 2017
    Report Date
    September 25, 2017
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KWD
    PMA / PMN Number
    K131377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE MTP HEMICAP DEVICE REMAINS IMPLANTED IN THE PATIENT AND THEREFORE WILL NOT BE RETURNED, THEREFORE NO PRODUCT EVALUATION IS CONDUCTED. NO X-RAYS, SCANS, PICTURES, PHYSICIAN'S REPORTS ETC., WERE PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THE REPORTED ISSUES. A REVIEW OF DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT CONDUCTED AS PART AND LOT NUMBER OF THE DEVICES INVOLVED ARE UNKNOWN. HOWEVER, ACCORDING TO THE PATIENT'S SURGEON, THE REPORTED ISSUES MAY BE RELATED TO PATIENT CONDITION. THE OUTCOME OF A SURGERY DEPENDS ON SEVERAL FACTORS SUCH AS PATIENT'S BONE QUALITY, SURGICAL OPERATING TECHNIQUE, COMPLIANCE TO POST-OPERATIVE REHABILITATION ETC., IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MDR WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE PATIENT REACHED OUT TO ARTHROSURFACE VIA WEBSITE TO INQUIRE ABOUT PAIN AND LOSS OF RANGE OF MOTION SHE IS CURRENTLY EXPERIENCING. SHE RECEIVED AN ARTHROSURFACE MTP HEMICAP DEVICE IN (B)(6) 2017 AND IS UNDERGOING PT PER SURGEON'S RECOMMENDATION TO OBTAIN PAIN RELIEF FROM THE SCAR TISSUE. HOWEVER, THE PATIENT IS STILL HAVING CONTINUED PAIN AND CONCERNS ABOUT RANGE OF MOTION. DURING A RECENT FOLLOW-UP VISIT, HET TREATING SURGEON TOLD THAT THE PAIN MAY BE DUE TO THE FRICTION BETWEEN THE BONES ON EITHER SIDE OF THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755614 HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT MTP HEMI-TOE PROSTHESIS KWD ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1