BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,41

    MDR report key: 7230975 · Received January 31, 2018

    Report

    Report Number
    1818910-2018-52469
    Event Type
    Injury
    Date Received
    January 31, 2018
    Date of Event
    January 11, 2018
    Report Date
    January 11, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232636
    PMA / PMN Number
    K961685
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE PHOTOGRAPH OF THE DEVICE(S) CONFIRMS THE REPORTED EVENT. PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: 1891339 DEVICE HISTORY REVIEW ==> NO ANOMALIES IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    REVISION OF PATELLA DR (B)(6), (B)(6) HOSPITAL, (B)(6) 2018. PATIENT UNDERWENT BILATERAL PRIMARY TKR ON (B)(6) 2005 (NOT CERTAIN) BY DR (B)(6) AT (B)(6) HOSPITAL). THIS IS THE 1ST REVISION FOR MALTRACKING PATELLA WITH PAIN, LOOSE PATELLA COMPONENT; PATIENT HAS REPORTED ANTERIOR KNEE PAIN A NUMBER OF YEARS AGO WHICH HAS BEEN GETTING PROGRESSIVELY WORSE. X RAYS SHOW THAT THE PATELLA IS DISLOCATING/ TRACKING LATERALLY. DR (B)(6) UNDERTOOK A ARTHROSCOPE ON (B)(6) 2018. UPON SCOPING THE KNEE, THE PATELLA COMPONENT WAS SEEN TO BE LOOSE. REVISION SURGERY WAS SCHEDULED FOR THE FOLLOWING DAY ((B)(6) 2018). UPON OPENING THE KNEE THE PATELLA COMPONENT WAS LOOSE AND "FLOATING" AROUND THE JOINT. IT APPEARED THAT THE BUTTON AND BROKEN OFF THE 3 LUGS. THE PATELLA WAS PREPARED BY RESECTING OFF OLD BONE AND A NEW 41MM PATELLA IMPLANTED. A LATERAL FACETECTOMY AND LATERAL RELEASE WAS ALSO UNDERTAKEN. TRACKING OF THE PATELLA WAS GOOD (NO THUMB TECHNIQUE) MALE PATIENT INITIALS: (B)(6). DOI:(B)(6) 2005; DOR: (B)(6) 2018; UNKNOWN KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74574 PFC*SIGMA/OV/DOME PAT 3PEG,41 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US 1891339 10603295232636

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention