BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFILL 5CC

    MDR report key: 6114257 · Received November 18, 2016

    Report

    Report Number
    3008812173-2016-00028
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    November 9, 2012
    Report Date
    October 20, 2016
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    MQV
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A CLINICAL STUDY ADVERSE EVENT ORIGINATED BY THE REVIEW OF CLINICAL DATA. INVESTIGATION IS STILL IN PROGRESS. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    INDEPENDENT REVIEW WAS CONDUCTED OF THE CLINICAL DOCUMENTATION FROM THE STUDY REGARDING THE PATIENT CONDITION AND TREATMENT. PER THE KNEE FOLLOW-UP REPORT (B)(6) 2012, THE PATIENT UNDERWENT MULTIPLE KNEE SURGERIES INCLUDING CARTICEL AND WAS STILL EXPERIENCING KNEE PAIN. PER THE (B)(6) 2013 OPERATIVE NOTES, THE PATIENT RETURNED WITH INCREASED PAIN IN (B)(6) 2013. MRI CONFIRMED AT THAT TIME THAT THE PATIENT HAD MEDIAL COMPARTMENT CHONDROSIS IN THE FEMORAL CONDYLE AND TIBIAL PLATEAU. SUBCHONDROPLASTY WAS CONDUCTED WITH ARTHROSCOPY AT THAT TIME. THE PATIENT RETURNED WITH CONTINUED KNEE PAIN. SURGERY WAS PERFORMED ON (B)(6) 2013 - OSTEOCHONDRAL ALLOGRAFT IMPLANTS WITH SUBCHONDROPLASTY FOR THE SAME AREA OF THE KNEE. IN THE KNEE POST-OP REPORT (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT WAS DOING WELL AND VERY PLEASED WITH THE TREATMENT. THE CHONDROSIS WAS REPORTED PRIOR TO THE INITIAL SUBCHONDROPLASTY TREATMENT - THE PATIENT HAS HAD MULTIPLE KNEE SURGERIES PRIOR TO THE INITIAL SCP TREATMENT. AFTER THE SECOND SCP SURGERY THE PATIENT WAS "VERY PLEASED" WITH HER KNEE. IS IT DOCUMENTED THAT THE SCP TREATMENT WAS NOT THE CAUSE OF THE CHONDROSIS. THE CAUSE OF THE KNEE PAIN AFTER THE INITIAL SCP SURGERY CANNOT BE DETERMINED. AFTER THE SECOND SCP SURGERY THE MATTER WAS REPORTED AS RESOLVED.

    Description of Event or Problem · 1

    CLINICAL SUBJECT ORDERED (B)(4) ADDITIONAL SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    CLINICAL SUBJECT (B)(4) ADDITIONAL SURGICAL INTERVENTION. DR. (B)(6) REPORTED EXTENSIVE CHONDROSIS MFC AND MTP AS WELL AS SUBCHONDRAL EDEMA/STRESS REACTION MFC AND MTP AS OF (B)(6) 2012, PRIOR TO SUBCHONDROPLASTY PROCEDURE. THESE EVENTS WORSENED TO MODERATE SEVERITY AND ULTIMATELY REQUIRED AN ADDITIONAL SURGICAL INTERVENTION ON (B)(6) 2013 OF OSTEOCHONDRAL ALLOGRAFT IN THE MEDIAL FEMORAL CONDYLE, AS WELL AS SUBCHONDROPLASTY TO THE MEDIAL TIBIAL PLATEAU; IT WAS NOT RELATED TO THE PROCEDURE BUT WAS POSSIBLY RELATED TO THE STUDY DEVICE. DURING A POST-OPERATIVE CLINIC VISIT ON (B)(6) 2013, DR. (B)(6) DEEMED THE ADVERSE EVENTS TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764612 ACCUFILL 5CC CALCIUM PHOSPHATE COMPOUND BONE VOID FILLER MQV ZIMMER KNEE CREATIONS, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other