BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 5

    MDR report key: 8830119 · Received July 26, 2019

    Report

    Report Number
    3005180920-2019-00619
    Event Type
    Injury
    Date Received
    July 26, 2019
    Date of Event
    June 28, 2019
    Report Date
    July 26, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804212
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 JULY 2019: LOT 173449: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOVEMBER-2017. EXPIRATION DATE: 2022-10-30. 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. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 11 JULY 2019: BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL +8 (K112115). LOT 167394: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-FEB-2017. EXPIRATION DATE: 2022-02-02. 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 Ø36/F (K103721). LOT 182616: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JULY-2018. EXPIRATION DATE: 2023-06-25. 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. MPACT 01.31.55TP SHELL SCREW PLUG (K103721). LOT 184748: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUNE-2018. EXPIRATION DATE: 2023-06-03. ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON FOUND SIGNS OF AN INFECTION 1 YEAR AND 8 MONTHS AFTER THE PRIMARY. THE PATIENT IS UNDER PHARMACOLOGICAL TREATMENT. THE REVISION SURGERY HAS NOT BEEN PERFORMED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624421 STEM: AMISTEM H HA COATED LAT STEM SIZE 5 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 173449 07630030804212

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention