BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 2 STD

    MDR report key: 6740210 · Received July 25, 2017

    Report

    Report Number
    3005180920-2017-00407
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    June 28, 2017
    Report Date
    July 25, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 21 JULY 2017 THE (B)(4) PERFORMED A CLINICAL EVALUATION BASED ON THE AVAILABLE PICTURES AND COMMENTED AS FOLLOWS: SIX YEARS AFTER PRIMARY CEMENTLESS THA THE FEMORAL STEM WAS GIVING PAIN AND WAS REPLACED. THE ONE RADIOGRAPH SUPPLIED SHOWS RADIOLUCENT SIGNS IN GRUEN ZONE 1 AND A RATHER DEEPLY IMPLANTED CUP: WE CANNOT KNOW IF THE CUP MIGRATED OVER THE YEARS OR THIS IS THE ORIGINAL IMPLANTATION POSITION. THE CAUSE FOR THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. BATCH REVIEWS PERFORMED ON 25 JULY 2017. LOT 110850: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 MAY 2011. EXPIRATION DATE: 2016-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THIS LOT (COMPLAINT (B)(4)). COCR BALL HEAD 12/14 Ø 28 SIZE XL +7, CODE 01.25.014, LOT. 103019 (K072857) LOT 103019: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 NOVEMBER 2010. EXPIRATION DATE: 2015-10-30. 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. VERSAFITCUP DOUBLE MOBILITY LINER Ø50/28, CODE 01.26.2850M, LOT. 110325 (K083116) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 APRIL 2011. EXPIRATION DATE: 2016-02-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE; EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522689 AMISTEM H, HA COATED STEM SIZE 2 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 110850 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention