BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 2

    MDR report key: 8826048 · Received July 25, 2019

    Report

    Report Number
    3005180920-2019-00618
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    June 28, 2019
    Report Date
    June 25, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804182
    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 09-JULY-2019: LOT 175338: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOVEMBER-2017. EXPIRATION DATE: 2022-10-24. 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. ADDITIONAL DEVICES INVOLVED: BATCHES REVIEW PERFORMED ON 09-JULY-2019: CUP: MPACT 01.32.150DH ACETABULAR SHELL Ø50 TWO-HOLES (K132879) LOT 188867: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEBRUARY-2019. EXPIRATION DATE: 2024-02-18. 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. BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 (K112115) LOT 188867: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEBRUARY-2019. EXPIRATION DATE: 2024-02-18. 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. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT 1810216: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DECEMBER-2018. EXPIRATION DATE: 2023-11-28. 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 1903028: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-APRIL-2019. EXPIRATION DATE: 2024-03-13. 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 SURGEON FOUND SIGNS OF AN INFECTION ONE MONTH AFTER PRIMARY SURGERY. 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
    620258 STEM: AMISTEM H HA COATED LAT STEM SIZE 2 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 175338 07630030804182

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention