BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK RESURFACING PATELLA SIZE 2

    MDR report key: 5239222 · Received November 20, 2015

    Report

    Report Number
    3005180920-2015-00277
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    October 21, 2015
    Report Date
    February 17, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 20 JANUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 21 JANUARY 2016, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 150873: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Description of Event or Problem · 1

    TWO WEEKS POST-OPERATIVE THE PATIENT WAS UNDERGOING REHABILITATION. WHILE USING THE CONTINUOUS PASSIVE MOTION MACHINE THE PATIENT FELT A POP ON THE MEDIAL SIDE OF HIS KNEE. THE PATIENT DID NOT REPORT HIS EXPERIENCE TO THE SURGEON. THE SUTURE BROKE AND THE PATELLA LATERALIZED AND DISLOCATED. WHEN THE PATIENT NOTIFIED THE SURGEON OF THE PROBLEM HE DID A LATERAL RELEASE, VASTUS MEDIALIS OBLIQUE AND A MEDIAL CAPSULAR PLICATION. THE #2 PATELLA WAS REPLACED WITH A #1 PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE. THE EXPLANT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770272 GMK RESURFACING PATELLA SIZE 2 RESURFACING PATELLA JWH MEDACTA INTERNATIONAL SA 150873

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention