BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / LEFT

    MDR report key: 7718471 · Received July 25, 2018

    Report

    Report Number
    3005180920-2018-00537
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    June 25, 2018
    Report Date
    October 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820984
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL REPORT DUE TO TYPO IT WAS NOT REPORTED THE MANUFACTURING DATE OF THE LOT: 160181. LOT: 160181: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 APRIL 2016 .

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 JULY 2018. LOT 151533: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 JUNE 2015. EXPIRATION DATE: 2021-03-15. 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. OTHER DEVICES INVOLVED: TIBIAL TRAY FIXED CEMENTED SIZE 3 L REFERENCE 02.07.1203L (K090988). LOT 156116: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 JANUARY 2016. EXPIRATION DATE: 2021-01-10. 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. TIBIAL INSERT PS FIXED SIZE 3/10MM REFERENCE 02.07.0310PSF (K090988). LOT 143610: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 OCTOBER 2014. EXPIRATION DATE: 2019-08-31. 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. PATELLA RESURFACING SIZE 2 REFERENCE 02.07.0034RP (K090988). LOT 160181: (B)(4) ITEMS MANUFACTURED AND RELEASED ON. 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 CALLED MEDACTA US COMPLAINING OF PAIN. THE PATIENT WILL LIKELY UNDERGO ADDITIONAL SURGERY. THE DATE OF THE REVISION IS UNKNOWN. THE REVISING SURGEON IS UNKNOWN. NO ADDITIONAL INFORMATION WILL BE PROVIDED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561767 GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / LEFT CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 151533 07630030820984

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention