BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005180920-2018-00584

    MDR report key: 7734710 · Received July 31, 2018

    Report

    Report Number
    3005180920-2018-00584
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    July 9, 2018
    Report Date
    October 31, 2018
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED ON 27 AUGUST 2018 BY R&D PRODUCT MANAGER: FEMORAL HEAD AND SHELL SHOW SIGNS OF DIFFICULT EXTRACTION AND VERY GOOD SIGNS OF OSTEOINTEGRATION WITH RESIDUAL BONE ON THE SURFACES. CERAMIC FEMORAL IS BROKEN IN FEW PARTS, PROBABLY DURING EXTRACTION. IT IS NOT POSSIBLE TO LINK THE INFECTION TO THE COMPONENTS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED ON OCTOBER 5, 2018 BY MUSA: THE HEAD BROKE DURING THE REMOVAL.

    Additional Manufacturer Narrative · 1

    PATHOGEN UNKNOWN. ON 26 JULY 2018 THE MEDICAL AFFAIRS MANAGER MADE THE FOLLOWING ANALYSIS: LATE INFECTION IN CEMENTLESS THA, 2 YEARS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEWS PERFORMED ON 26 JULY 2018: LOT 131626: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 JULY 2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEW FOR MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S REF. 01.29.201 LOT. 160542 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 APRIL 2016. EXPIRATION DATE: 2021-04-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT. BATCH REVIEW FOR VERSAFITCUP ACETABULAR SHELL Ø 48 REF. 01.26.48MB LOT. 157075 (K083116): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-03-20. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEW FOR VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 48/28 REF. 01.26.2848MHC LOT. 157121 (K092265): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MARCH 2016. EXPIRATION DATE: 2021-03-06. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON DETERMINED THAT INDEED INFECTION WAS PRESENT AND THAT REMOVAL OF THE IMPLANTS WAS NECESSARY. THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2018

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention