BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø52 TWO-HOLES

    MDR report key: 7826831 · Received August 29, 2018

    Report

    Report Number
    3005180920-2018-00633
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 29, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 AUGUST 2018; LOT 174500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 DECEMBER 2017. EXPIRATION DATE: 2022-12-03; 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. OTHER DEVICES INVOLVED AMISTEM-H PROXIMAL COATING STD STEM REFERENCE 5 SIZE 01.18.175 (K161635); LOT 173526: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 NOVEMBER 2017. EXPIRATION DATE: 2022-11-05; 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. MPACT FLAT PE HC LINER Ø36/E REFERENCE 01.32.3644HCT (K103721); LOT 171740: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-20; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 REFERENCE 01.29.210 (K112115); LOT 176388: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JANUARY 2018. EXPIRATION DATE: 2022-12-26; 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. CLINICAL EVALUATION PERFORMED ON 24 AUGUST 2018 BY MEDICAL AFFAIRS MANAGER SECOND REVISION DUE TO UNSOLVED INFECTION 4 MONTHS AFTER FIRST REVISION. 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. VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON 29 AUGUST 2018; FEMORAL STEM SHOWS RESIDUAL BONE AND HYDROXYAPATITE LAYER STILL VISIBLE, HOWEVER, IT LOOKS THAT ITS ABSORPTION WAS ACTIVATED. HEAVY SIGNS OF STEM EXTRACTION VISIBLE ON ALL THE FEMORAL STEM. FEMORAL HEAD SHOWS SIGNS OF THE EXTRACTION PROCEDURE. ACETABULAR SHELL SHOWS RESIDUAL BONE AND GOOD SIGNS OF OSSEOINTEGRATION. EXTRACTION SIGNS ARE VISIBLE ON THE EDGE. PE LINER IS STRANGELY SHRUNK WITH RESPECT TO THE SHELL CAVITY, PROBABLY DUE TO THE STERILIZATION PROCESS.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION ABOUT 5 MONTHS AFTER THE PREVIOUS SURGERY DONE FOR INFECTION. THE FIRST INFECTION DID NOT SUBSIDE [PATHOGEN: STAPHYLOCOCCUS]. THE SURGEON REMOVED ALL THE DEVICES AND IMPLANTED A SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667970 MPACT ACETABULAR SHELL Ø52 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 174500 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention