BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM HA COATED STD STEM SIZE 6

    MDR report key: 9144401 · Received October 2, 2019

    Report

    Report Number
    3005180920-2019-00844
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    September 6, 2019
    Report Date
    October 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804120
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 SEPTEMBER 2019: LOT 160645: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAY-2016. EXPIRATION DATE: 2021-04-25. 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. ADDITIONAL DEVICE INVOLVED. BATCH REVIEWS PERFORMED ON 10 SEPTEMBER 2019: CUP: MPACT 01.32.160DH ACETABULAR SHELL Ø60 TWO-HOLES (K132879) LOT 161861: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-SEP-2016. EXPIRATION DATE: 2021-09-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 165970: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2017. EXPIRATION DATE: 2021-12-19. 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

    THE PATIENT CAME IN, 2 YEARS AND 3 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN, AFTER INVESTIGATION THERE WAS EVIDENCE OF INFECTION. A REVISION SURGERY WAS PERFORMED AND ALL THE IMPLANTS HAVE BEE REMOVED. AN ANTIBIOTIC CEMENT WAS USED TO LIGHTLY CEMENT SMALL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942492 STEM: AMISTEM HA COATED STD STEM SIZE 6 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 160645 07630030804120

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R