BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBCHONDROPLASTY

    MDR report key: 7120538 · Received December 15, 2017

    Report

    Report Number
    3008812173-2017-00028
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 13, 2014
    Report Date
    March 1, 2018
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    OJH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS DRIVEN FROM A CLINICAL STUDY; A TOTAL KNEE REPLACEMENT SURGERY TOOK PLACE AFTER THE SCP PROCEDURE. THE HCP STATED THE AE HAS A REMOTE POSSIBILITY IT IS RELATED TO THE DEVICE. IN AN EFFORT TO BE CONSERVATIVE, THIS COMPLAINT WILL BE TREATED AS A SERIOUS INJURY AND WILL BE INVESTIGATED FURTHER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION ABOUT THE INITIAL SCP SURGERY WAS UNABLE TO BE OBTAINED, AS THE NAME OF DOCTOR WHO PERFORMED THE INITIAL SCP SURGERY WAS NOT PROVIDED TO THE DOCTOR WHO PERFORMED THE TKA. ALTHOUGH, THE OPERATIVE NOTES STATE THE PATIENT ALSO HAD A MEDIAL MENISCUS TEAR, PROBABLE LATERAL MENISCUS TEAR, TRICOMPARTMENTAL CHONDROSIS AND A MEDIAL TIBIAL PLATEAU STRESS FRACTURE. HE UNDERSTOOD THAT HE WOULD NEED ARTHROPLASTY AS SOME POINT, BUT WOULD LIKE TO DELAY THE PROCEDURE.

    Description of Event or Problem · 1

    TKA AFTER SCP CLINICAL STUDY SUBJECT.

    Description of Event or Problem · 1

    TKA AFTER (B)(6) CLINICAL STUDY SUBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899374 SUBCHONDROPLASTY SCP KIT OJH ZIMMER KNEE CREATIONS, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other