BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 8023972 · Received October 31, 2018

    Report

    Report Number
    3005180920-2018-00849
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    October 3, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31 OCTOBER 2018: LOT 178447: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-APRIL-2018. EXPIRATION DATE: 2023-03-23. 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 COMPONENTS INVOLVED (DISLOCATION) AND REVISED: LINER: CC E CC LIGHT 01.26.3239 HCT FLAT PE HC LINER Ø 32 / C, (K120531). LOT 144764: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-SEPTEMBER-2014. EXPIRATION DATE: 2019-08-31. 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. BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4, (K112115). LOT 162726: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JULY-2016. EXPIRATION DATE: 2021-07-19. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEW DAYS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY, THE STEM ROTATED IN THE FEMUR AND THE HIP DISPLACED. THE STEM COULDN'T FIND INITIAL FIXATION IN THE BONE THAT HAS A DORR C CONFIGURATION AND A LOW DENSITY. WE DO NOT SEE ANY REASON WHY THIS LACK OF INITIAL STABILITY COULD BE ASCRIBED TO A DEFECT IN THE DEVICE.

    Description of Event or Problem · 1

    PATIENT CAME IN COMPLAINING OF PAIN 7 DAYS AFTER PRIMARY. THE STEM ROTATED IN THE FEMORAL CANAL DUE TO POOR BONE QUALITY. THE HEAD DISLOCATED FROM THE LINER. THE SURGEON REVISED ALL MEDACTA COMPONENTS AND REVISED WITH A MEDACTA BIPOLAR SYSTEM. THE SURGERY WAS PERFORMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866271 STEM: AMISTEM H HA COATED STD STEM SIZE 2 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 178447 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention