BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5

    MDR report key: 6740185 · Received July 25, 2017

    Report

    Report Number
    3005180920-2017-00406
    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
    JDI
    UDI-DI
    07630030805172
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. ON (B)(6) 2017 THE PATIENT HAD A REVISION OF NON-MEDACTA PRODUCTS DUE TO INFECTION. ON 21 JULY 2017 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION BASED ON THE AVAILABLE PICTURES AND COMMENTED AS FOLLOWS: HIP DISLOCATION FEW MONTHS AFTER REVISION HIP ARTHROPLASTY FOLLOWING INFECTION. A NEW HEAD, IN THE FINAL OPERATION, TWO SIZES LONGER THAN THE PREVIOUS ONE WAS USED TO RESTORE SOFT TISSUE TENSION AND POSSIBLY LEG LENGTH. THIS MAY BE THE CONSEQUENCE OF STEM SUBSIDENCE (A POSSIBLE SEQUELA AFTER INFECTION) OR FOR INSUFFICIENT TENSION ACHIEVED DURING THE FIRST REVISION SURGERY: THE FORMER IMAGES ARE NOT AVAILABLE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. BATCH REVIEWS PERFORMED ON 25 JULY 2017. LOT 152724: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 OCTOBER 2015. EXPIRATION DATE: 2020-10-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT. VERSAFITCUP FLAT PE HC LINER Ø 32 / F, CODE 01.26.3248HCT, LOT. 164467 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 OCTOBER 2016. EXPIRATION DATE: 2021-09-22. 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

    REVISION SURGERY DUE TO HIP LUXATION. HEAD AND LINER WERE EXPLANTED. NO TRAUMA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522228 COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 152724 07630030805172

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention