BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3

    MDR report key: 9744696 · Received February 24, 2020

    Report

    Report Number
    3005180920-2020-00089
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    January 27, 2020
    Report Date
    February 24, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720120
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31 JANUARY 2020: LOT 182543: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-SEP-2018. EXPIRATION DATE: 2023-09-04. 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 IMPLANTS INVOLVED IN THE COMPLAINT, BATCH REVIEW PERFORMED ON 31 JANUARY 2020. CUP: MPACT 01.32.156DH ACETABULAR SHELL 56 TWO-HOLES (K132879) LOT. 1901381 LOT 1901381: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2019. EXPIRATION DATE: 2024-05-21. 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. SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD 6,5 L 30 (K103721) LOT. 1904928 LOT 1904928: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-30. 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. SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD 6,5 L 25 (K103721) LOT. 1904927 LOT 1904927: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-29. 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. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER 36/F (K103721) LOT. 185988 LOT 185988: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2018. EXPIRATION DATE: 2023-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE L + 4 (K112115) LOT. 1901948 LOT 1901948: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2019. EXPIRATION DATE: 2024-06-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER MORE THAN 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211185 STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 182543 07630040720120

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention