BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5

    MDR report key: 6705102 · Received July 12, 2017

    Report

    Report Number
    3005180920-2017-00367
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 12, 2017
    Report Date
    July 12, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805141
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: 7.5 YEARS AFTER PRIMARY CEMENTLESS DM THA THE PATIENT REPORTED PAIN, SO HEAD AND LINER WERE EXCHANGED. THE DOCUMENTATION SUPPLIED ONLY INCLUDES ONE AP PRE-REVISION XRAY, WHICH SHOWS, APPARENTLY, SOME DEGREE OF LEG SHORTENING ON THE RIGHT SIDE (THE REVISED SIDE). WE COULD NOT ESTABLISH WHETHER THE SHORTENING INTERVENED WITH TIME OR WAS AN OUTCOME OF PRIMARY SURGERY, OR INDEED IF THE CONTRALATERAL SIDE HAD BEEN LENGTHENED AFTERWARDS (LESS LIKELY). A BONE FRAGMENT ABOVE THE ACETABULAR ROOF IS PROBABLY NOT RELEVANT TO THE PROBLEM. THE ACETABULAR CUP MIGHT HAVE TILTED AND MIGRATED FROM ITS ORIGINAL POSITION, BUT THIS COULD NOT BE VERIFIED WITH THE INFORMATION AT HAND. THE CAUSE FOR THE SECOND OPERATION COULD NOT BE DETERMINED WITH CERTAINTY. ON (B)(6) 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE PARTS WERE ANALYZED. THE COBALT CHROME FEMORAL HEAD WAS INSIDE THE PE DOUBLE MOBILITY LINER. THE EXTERNAL SURFACE OF THE LINER APPEARED SLIGHTLY YELLOWED BUT IN GOOD CONDITIONS, WHILE THE INNER SOCKET SHOWED SOME SMALL PARTS OF TISSUE, MOST PROBABLY BLOOD. MOREOVER, THE INNER BOTTOM SURFACE OF THE BALL HEAD APPEARED TO BE DIRTY OF BLOOD TOO. FROM THE ANALYSIS OF THE PIECES IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. BATCH REVIEW PERFORMED ON 10 JULY 2017. LOT 072406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 DECEMBER 2007. EXPIRATION DATE: 2012-10-31. 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 LINER Ø 60/28, CODE 01.26.2860M, LOT. 090903 (K083116) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JUNE 2009. EXPIRATION DATE: 2014-04-30. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE; EXPLANTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486732 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 072406 07630030805141

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention