BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK 5.5MM HEALIX ADVANCE PEEK ANCHOR W/ORTHOCORD

    MDR report key: 4682922 · Received April 12, 2015

    Report

    Report Number
    1221934-2015-00689
    Event Type
    Injury
    Date Received
    April 12, 2015
    Date of Event
    November 12, 2014
    Report Date
    March 13, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K120449
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK HOWEVER IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY SYNTHES MITEK. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITH TWO UNRELATED INCIDENTS AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT APPROXIMATELY THREE WEEKS AFTER HAVING SURGERY (B)(6) 2014, SHE DEVELOPED A RAISED, ANNULAR, AND RED RASH ON THE SURGICAL ARM AND SHOULDER AREA. SHE SOUGHT TREATMENT WAS GIVEN ANTIBIOTICS AND TOPICAL STEROID MEDICATIONS WITH NO IMPROVEMENT. THE RASH RESOLVED ON ITS OWN AFTER ABOUT FOUR WEEKS. THE PATIENT THEN EXPERIENCED PAIN AND LOST SHOULDER MOBILITY. ON (B)(6) 2014 THE PATIENT UNDERWENT SHOULDER ARTHROSCOPIC EXPLORATION. FINDINGS WERE RECURRENT ROTATOR CUFF TEAR, OSTEOLYSIS, CHONDRAL DAMAGE, SYNOVITIS, AND PARTICULATE DEBRIS. APPROXIMATELY THREE WEEKS LATER SHE DEVELOPED A VERY SIMILAR RED, RAISED, ANNULAR RASH AND AGAIN IT WAS UNRESPONSIVE TO MEDICATIONS. THE RASH BECAME WORST AND SPREAD THROUGHOUT THE SURGICAL ARM AND SHOULDER. AT THIS POINT THE PATIENT WAS REFERRED TO A DERMATOLOGIST, WHO BIOPSIED THE AREA AND CAME BACK WITH FINDINGS SUGGESTIVE OF FOREIGN BODY REACTION. THE RASH STARTED TO SUBSIDE AT ABOUT EIGHT WEEKS BUT IS STILL MINIMALLY PRESENT WITH A RECENT SLIGHT FLARE UP OF THE RASH, COINCIDING TO SOME SHOULDER PAIN. THE FOLLOWING INFORMATION WAS RECEIVED FROM THE SURGEON'S MEDICAL ASSISTANT VIA PHONE ON 4-20-15; PRODUCT CODE 222305 WAS USED IN BOTH PROCEDURES, ONE WITH LOT NUMBER 3641785 WAS USED IN THE PROCEDURE ON (B)(6) 2014, AND ONE WITH LOT NUMBER 3753435 WAS USED IN THE PROCEDURE ON (B)(6) 2014. SEE ASSOCIATED MEDWATCH # 1221934-2015-00811.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT APPROXIMATELY THREE WEEKS AFTER HAVING SURGERY (B)(6) 2014, SHE DEVELOPED A RAISED, ANNULAR, AND RED RASH ON THE SURGICAL ARM AND SHOULDER AREA. SHE SOUGHT TREATMENT WAS GIVEN ANTIBIOTICS AND TOPICAL STEROID MEDICATIONS WITH NO IMPROVEMENT. THE RASH RESOLVED ON ITS OWN AFTER ABOUT FOUR WEEKS. THE PATIENT THEN EXPERIENCED PAIN AND LOST SHOULDER MOBILITY. ON (B)(6) 2014, THE PATIENT UNDERWENT SHOULDER ARTHROSCOPIC EXPLORATION. FINDINGS WERE RECURRENT ROTATOR CUFF TEAR, OSTEOLYSIS, CHONDRAL DAMAGE, SYNOVITIS, AND PARTICULATE DEBRIS. APPROXIMATELY THREE WEEKS LATER SHE DEVELOPED A VERY SIMILAR RED, RAISED, ANNULAR RASH AND AGAIN IT WAS UNRESPONSIVE TO MEDICATIONS. THE RASH BECAME WORST AND SPREAD THROUGHOUT THE SURGICAL ARM AND SHOULDER. AT THIS POINT THE PATIENT WAS REFERRED TO A DERMATOLOGIST, WHO BIOPSIED THE AREA AND CAME BACK WITH FINDINGS SUGGESTIVE OF FOREIGN BODY REACTION. THE RASH STARTED TO SUBSIDE AT ABOUT EIGHT WEEKS BUT IS STILL MINIMALLY PRESENT WITH A RECENT SLIGHT FLARE UP OF THE RASH, COINCIDING TO SOME SHOULDER PAIN.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT APPROXIMATELY THREE WEEKS AFTER HAVING SURGERY (B)(6) 2014, SHE DEVELOPED A RAISED, ANNULAR, AND RED RASH ON THE SURGICAL ARM AND SHOULDER AREA. SHE SOUGHT TREATMENT WAS GIVEN ANTIBIOTICS AND TOPICAL STEROID MEDICATIONS WITH NO IMPROVEMENT. THE RASH RESOLVED ON ITS OWN AFTER ABOUT FOUR WEEKS. THE PATIENT THEN EXPERIENCED PAIN AND LOST SHOULDER MOBILITY. ON (B)(6) 2014 THE PATIENT UNDERWENT SHOULDER ARTHROSCOPIC EXPLORATION. FINDINGS WERE RECURRENT ROTATOR CUFF TEAR, OSTEOLYSIS, CHONDRAL DAMAGE, SYNOVITIS, AND PARTICULATE DEBRIS. APPROXIMATELY THREE WEEKS LATER SHE DEVELOPED A VERY SIMILAR RED, RAISED, ANNULAR RASH AND AGAIN IT WAS UNRESPONSIVE TO MEDICATIONS. THE RASH BECAME WORST AND SPREAD THROUGHOUT THE SURGICAL ARM AND SHOULDER. AT THIS POINT THE PATIENT WAS REFERRED TO A DERMATOLOGIST, WHO BIOPSIED THE AREA AND CAME BACK WITH FINDINGS SUGGESTIVE OF FOREIGN BODY REACTION. THE RASH STARTED TO SUBSIDE AT ABOUT EIGHT WEEKS BUT IS STILL MINIMALLY PRESENT WITH A RECENT SLIGHT FLARE UP OF THE RASH, COINCIDING TO SOME SHOULDER PAIN. THE FOLLOWING INFORMATION WAS RECEIVED FROM THE SURGEON'S MEDICAL ASSISTANT VIA PHONE ON (B)(6) 2015; PRODUCT CODE 222305 WAS USED IN BOTH PROCEDURES, ONE WITH LOT NUMBER 3641785 WAS USED IN THE PROCEDURE ON (B)(6) 2014, AND ONE WITH LOT NUMBER 3753435 WAS USED IN THE PROCEDURE ON (B)(6) 2014. SEE ASSOCIATED MEDWATCH # 1221934-2015-00811.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243913 MITEK 5.5MM HEALIX ADVANCE PEEK ANCHOR W/ORTHOCORD ANCHOR IMPLANTS HWC DEPUY MITEK NA 3641785

    Patients

    Seq Age Sex Outcome Treatment
    1 Other