BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1

    MDR report key: 11676929 · Received April 16, 2021

    Report

    Report Number
    3005180920-2021-00305
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 16, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720007
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 MARCH 2021: LOT 2004808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-SEP-2020. EXPIRATION DATE: 2025-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT. 2009610. BATCH REVIEW PERFORMED ON 25 MARCH 2021: LOT 2009610: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2020. EXPIRATION DATE: 2025-10-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2006697. BATCH REVIEW PERFORMED ON 25 MARCH 2021: LOT 2006697: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2020. EXPIRATION DATE: 2025-09-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW FOR CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES (K132879) LOT. 2001283. BATCH REVIEW PERFORMED ON 25 MARCH 2021: LOT 2001283: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JULY-2020. EXPIRATION DATE: 2025-06-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT. 2003333. BATCH REVIEW PERFORMED ON 24 MARCH 2021: LOT 2003333: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2020. EXPIRATION DATE: 2025-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2006694. BATCH REVIEW PERFORMED ON 24 MARCH 2021: LOT 2006694: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2020. EXPIRATION DATE: 2025-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY REPORTING PAIN DUE TO FALLING. THE SURGEON OBSERVED REDNESS AND SWELLING AT THE INCISION SITE AND DECIDED TO PERFORM A WASHOUT AND REVISE THE HEAD AND LINER. 1 DAY AFTER THE REVISION THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574028 STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 2004808 07630040720007

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention