BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52

    MDR report key: 7793275 · Received August 17, 2018

    Report

    Report Number
    3005180920-2018-00612
    Event Type
    Injury
    Date Received
    August 17, 2018
    Date of Event
    July 26, 2018
    Report Date
    August 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807770
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 AUGUST 2018; LOT 172505: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-28; 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: REFERENCE 01.26.3644HCT (K120531) FLAT PE HC LINER Ø 36/ E; LOT 172577: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 AUGUST 2017. EXPIRATION DATE: 2022-07-23. 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. REFERENCE 01.12.21SN (K082792) CEMENTLESS, HA COATED STD STEM # 1, SHORT NECK; LOT 168107: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MARCH 2017. EXPIRATION DATE:2022-03-21; 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. REFERENCE 01.25.031 (K080885) COCR BALL HEAD 12/14 Ø 36 SIZE M 0; LOT 154625: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 DECEMBER 2015. EXPIRATION DATE: 2020-11-17; 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 31 JULY 2018 BY MEDICAL AFFAIRS MANAGER INFECTION IN CEMENTLESS THA, 1 YEAR 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.

    Description of Event or Problem · 1

    REVISION DUE TO INFECTION 9 MONTHS AFTER PRIMARY: ABSCESS FOUND. THE PATIENT STARTED COMPLAINING ABOUT PAIN IN (B)(6) 2018, AFTER AN URINARY INFECTION. AT THE LAB THERE WAS NO EVIDENCE OF ANY GERM. DURING REVISION THE STEM WAS NOT LOOSE BUT THE CUP WAS LOOSE AND IT WAS EASILY REMOVED: ALL THE IMPLANTS HAVE BEEN REMOVED AND AN CEMENT SPACER WITH ANTIBIOTICS HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633419 VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 172505 07630030807770

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention