BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 5384987 · Received January 22, 2016

    Report

    Report Number
    3005180920-2015-00395
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    December 24, 2015
    Report Date
    April 18, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05 JANUARY 2016, THE MEDICAL AFFAIRS PERFORMED THE FOLLOWING CLINICAL EVALUATION WHILE CHECKING THE X-RAY: ACCORDING TO REPORT, SIGNS OF INFECTION WERE DETECTED, FEW WEEKS AFTER PRIMARY THA. INFECTION NOT CONFIRMED YET, BUT FURTHER SURGERY WAS UNDERTAKEN IN ORDER (PROBABLY) TO CLEAN LOCALLY. DURING THIS PROCEDURE, HEAD AND INSERT WERE EXCHANGED: THIS IS STANDARD PROCEDURE IN SUCH A CASE AND THERE IS NO REASON TO SUSPECT THAT THE ORIGIN OF THE PROBLEM WAS IMPLANT RELATED. BATCH REVIEW PERFORMED ON 19 JANUARY 2016: LOT 151721: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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. DOUBLE MOBILITY HC LINER CODE 01.26.2850MHC, LOT. 152689 (K092265): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 SEPTEMBER 2015. EXPIRATION DATE: 2020-06-30. 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. ADDITIONAL INFORMATION RECEIVED ON 20 JAN 2016: THE PATHOLOGY WAS P. ACNES. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 23 MARCH 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON 05 APRIL 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT HAD SIGNS OF INFECTION SO THE SURGEON PERFORMED AN INCISION AND DRAINAGE OF HER HIP. THE HEAD AND LINER WERE SWAPPED OUT, USING A COBALT AND CHROMIUM HEAD, INSTEAD OF THE CERAMIC HEAD. THE EXPLANTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43567 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 151721

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention