BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 2

    MDR report key: 9155333 · Received October 4, 2019

    Report

    Report Number
    3005180920-2019-00840
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    December 14, 2018
    Report Date
    October 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804182
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2019: LOT 152218: 123 ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2015 . EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 115 THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEW MONTHS AFTER PRIMARY CEMENTLESS THA, THE PATIENT REPORTS PAIN AND THE STEM IS REVISED. WE HAVE VERY LIMITED INFORMATION, BUT THE SINGLE IMAGE PROVIDED DISPLAYS A VERY ANOMALOUS BONE CONDITION, WHOSE ORIGIN IS TOTALLY UNKNOWN TO US BUT IT CANNOT BE CONSIDERED ALIEN TO THE EARLY LOSS OF FIXATION. THOUGH WE ARE NOT INFORMED OF THE GENERAL HEALTH STATUS OF THIS PATIENT, THE PROBABILITY THAT THE GENERAL CONDITION DETERMINED THIS LOOSENING IS EXTREMELY HIGH, BASED ON OUR EXPERIENCE. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2019: BALL HEADS: COCR 01.25.123 COCR BALL HEAD 12/14 Ø 22 SIZE M 0 (K080885) LOT. 142883 LOT 142883: 19 ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2014 . EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: VERSAFITCUP DM 01.26.2246MHC DOUBLE MOBILITY HC LINER Ø 46/22.2 (K092265) LOT. 183111 LOT 183111: 24 ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2018 . EXPIRATION DATE: 2023-06-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 10 MONTHS AFTER THE PRIMARY DUE TO PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE STEM, LINER AND HEAD SUCCESSFULLY. THE IMPLANTS LOOKED WELL FIXED, THE CAUSE OF THE PAIN COULDN'T BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952968 STEM: AMISTEM H HA COATED LAT STEM SIZE 2 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 152218 07630030804182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention