BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMISTEM H, HA COATED STEM SIZE 5 STD

    MDR report key: 6878318 · Received September 20, 2017

    Report

    Report Number
    3005180920-2017-00525
    Event Type
    Death
    Date Received
    September 20, 2017
    Date of Event
    August 23, 2017
    Report Date
    September 20, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF DEATH WILL NOT BE DISCLOSED PER HOSPITAL POLICY. NO ADDITIONAL ANALYSIS WILL BE SHARED WITH MEDACTA PER HOSPITAL POLICY. BATCH REVIEWS PERFORMED ON (B)(6) 2017. LOT 168205: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 MAY 2017. EXPIRATION DATE: 2022-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, XXX ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 48, CODE 01.26.45.0048, LOT. 163918 (K103352). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPTEMBER 2016. EXPIRATION DATE: 2021-09-14. 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. VERSAFITCUP FLAT PE HC LINER Ø 32 / C, CODE 01.26.3239HCT, LOT. 170965 (K120531). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MAY 2017. EXPIRATION DATE: 2022-04-18. 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. CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 30, CODE 01.26.65.30, LOT. 171098 (K103352). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 APRIL 2017. EXPIRATION DATE: 2022-03-23. 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. CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 20, CODE 01.26.65.20, LOT. 170652 (K103352). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 MARCH 2017. EXPIRATION DATE: 2022-03-05. 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. COCR BALL HEAD 12/14 Ø 32 SIZE M 0, CODE 01.25.022, LOT. 163213 (K072857). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-21. 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

    DURING A PRIMARY HIP CASE, WHEN THE SURGEON WAS IMPLANTING THE STEM, THE PATIENT'S VITALS STARTED TO DROP (CUP, LINER AND SCREW WERE ALREADY IMPLANTED). THE SURGEON WAS ABLE TO IMPLANT THE HEAD BEFORE THE PATIENT CODED. CPR WAS PERFORMED. THE PATIENT WAS REVIVED. THE PATIENT WAS MOVED TO THE ICU. WHILE IN THE ICU THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660394 AMISTEM H, HA COATED STEM SIZE 5 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 168205 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death