BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DM ACETABULAR LINER

    MDR report key: 5232952 · Received November 18, 2015

    Report

    Report Number
    3005180920-2015-00267
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    October 19, 2015
    Report Date
    December 17, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 19 NOVEMBER 2015 THE R&D PROJECT MANAGER ANALYSED THE RETURNED IMPLANTS: OBSERVING THE EXPLANTED POLYETHYLENE LINER AND CERAMIC FEMORAL HEAD NO PARTICULAR SIGNS CAN BE SEEN. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT. ON 14 DEC 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND HERE ABOVE. ON 16 DEC 2015 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    UPDATE OF 22 OCT 2015: THE SURGEON DECIDED TO REVISE THE PATIENT DUE TO THE FACT THAT HE THOUGHT THERE WAS A POSSIBLE INFECTION. UPON OPENING THE PATIENT AND TAKING A CULTURE IT WAS DETERMINED THAT IN FACT THE PATIENT HAD AN INFECTION WITH THE LISTED BACTERIA. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) THE SURGEON DECIDED THAT A REVISION WAS NECESSARY AND HE SCHEDULED IT FOR THE FOLLOWING DAY (B)(6). THERE WERE NO CEMENT SPACERS PUT INTO THE PATIENT. I WILL ASK IF THERE ARE POST-OP(PRIMARY SURGERY) X-RAYS AVAILABLE ON 11 NOVEMBER THE MEDICAL AFFAIRS DIRECTOR CHECKED THE X-RAY COMMENTING AS FOLLOWING: PARTIAL REVISION OF MOBILE COMPONENTS (HEAD AND LINER) REPORTEDLY DUE TO INFECTION. BATCH REVIEW PERFORMED ON 18 NOVEMBER 2015: DOUBLE MOBILITY HC LINER CODE 01.26.2850MHC LOT. 151097: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 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 IMPLANTED WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L CODE 01.29.203 LOT. 146025 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 NOVEMBER 2014. EXPIRATION DATE: 2019-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE PATIENT HAD A HEMATOMA THAT WAS VACUUMED OUT. ON (B)(6) 2015 THE SURGEON DECIDED TO SWAP THE POLY OF THE PATIENT DUE TO POSSIBLE INFECTION. UPON OPENING THE PATIENT ON (B)(6) 2015 THE SURGEON REVISED THE HEAD AND LINER. EXPLANTS WILL BE RETURNED. PATHOLOGY: PROPIONIBACTERIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764831 DM ACETABULAR LINER ACETABULAR PE LINER MEH MEDACTA INTERNATIONAL SA 151097

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention