BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R

    MDR report key: 7832921 · Received August 30, 2018

    Report

    Report Number
    3005180920-2018-00645
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 30, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862403
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 AUGUST 2018; LOT 171028: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 MAY 2017. EXPIRATION DATE: 2022-05-08; 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: REFERENCE 02.07.1204R (K090988) TIBIAL TRAY FIXED CEMENTED # 4 R; LOT 170444: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 JUNE 2017. EXPIRATION DATE: 2022-05-17; 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. REFERENCE 02.12.0412FR (K121416) TIBIAL INSERT FIXED SPHERE FLEX #4/12 MM R; LOT 172821: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JULY 2017. EXPIRATION DATE:2022-06-23; 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 CAME IN DUE TO SIGNS OF INFECTION. [PATHOGEN: STAPH. COAGULASE-NEGATIVE]. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED A SPACER, ON AN UNKNOWN DATE. THE SURGEON IMPLANTED PERMANENT HARDWARE ON (B)(6) 2018. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676120 FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 171028 07630030862403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention