BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 2

    MDR report key: 7018027 · Received November 10, 2017

    Report

    Report Number
    3005180920-2017-00654
    Event Type
    Injury
    Date Received
    November 10, 2017
    Report Date
    November 10, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815751
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY TH PATIENT. DURING THE FIRST REVISION THE PATIENT FELL AND DISLOCATED HIS PATELLA. THE SURGEON FELT THE PATIENT'S KNEE WAS LOOSE. THE SURGEON SWAPPED THE POLY. THE PATELLA WAS IN GOOD CONDITION AND REMAINED IN THE PATIENT. IN (B)(6) 2017 THE PATIENT'S PATELLA WAS DISLOCATING AGAIN. BATCH REVIEWS PERFORMED ON 10 NOVEMBER 2017. LOT 166108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 NOVEMBER 2016. EXPIRATION DATE: 2021-11-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 LEFT, CODE 02.12.0006L, LOT. 161654 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 APRIL 2016. EXPIRATION DATE: 2021-04-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT'S PATELLA DISLOCATED. THE SURGEON FELT THE FEMUR WAS INTERNALLY ROTATED FROM THE INITIAL PRIMARY SURGERY, THEREBY CAUSING THE PATELLA TO NOT TRACK APPROPRIATELY. A REVISION SURGERY WAS PERFORMED TO REPLACE THE FEMORAL COMPONENT AND THE INSERT. THE PATELLAR COMPONENT WAS ALSO REMOVED, THE PATELLA RECUT AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796287 GMK-SPHERE PATELLA RESURFACING SIZE 2 PATELLA RESURFACING JWH MEDACTA INTERNATIONAL SA 166108 07630030815751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention