BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 3 STD

    MDR report key: 5694979 · Received June 2, 2016

    Report

    Report Number
    3005180920-2016-00261
    Event Type
    Injury
    Date Received
    June 2, 2016
    Date of Event
    May 5, 2016
    Report Date
    August 30, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 20 MAY 2016 THE CERAMIC MANUFACTURER FURTHER CONFIRMED THAT NO ANOMALIES WERE FOUND IN THE MANUFACTURING PROCESS FOR THE CERAMIC HEAD RELATED TO THE COMPLAINT, AND PROVIDED A DOCUMENT REVIEW REPORTING AS FOLLOWS: THE COMPONENT PROPERTIES AND MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT. DUE TO THE LACK OF CERAMIC PARTS, NO FURTHER INVESTIGATION COULD BE DONE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 11 MAY 2016 AND INCLUDES: THE CAUSE OF PAIN IS UNKNOWN. BATCH REVIEWS PERFORMED ON 02 JUNE 2016. LOT 150848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JUNE 2015. EXPIRATION DATE: 2020-05-31. 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. VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 62/28, CODE 01.26.2862MHC, LOT. 113330 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 OCTOBER 2011. EXPIRATION DATE: 2016-08-31. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5, CODE 01.29.203, LOT. 148656 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 MARCH 2015. EXPIRATION DATE: 2020-02-29. 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 Manufacturer Narrative · 1

    ON 31 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE PREVIOUS REPORTS. ON 12 AUGUST 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349229 AMISTEM H, HA COATED STEM SIZE 3 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 150848

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention