MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 46

Catalog Number	01.26.45.0046
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Update on the 29th august 2018 by sales representative: this revision hip replacement is now being operated on by another surgeon on (b)(6) 2018.Update sep 4, 2018 by sales representative: the case went ahead today (b)(6) 2018.Removed versafit cup 46 and 32 c hcpe liner due to aseptic loosening.No osteointegration of cup upon removal - may be due to infection, will know in 3-5 days.Head was also removed as changed from -3.5 (s) to 0 (m).Case was completed successfully.Update 17 september 2018 by sales representative: surgeon has responded the following in regards to pathogen results: no growth.Aseptic loosening.Clinical evaluation performed by medical affairs manager on 04 september 2018.Acetabular component and liner revision 4.5 years after primary cementless total hip arthroplasty.In the image provided the cup looks mobilized: the inital position cannot be assessed having a single pre-revision x-ray.According to the available information the presence of an active infection cannot be excluded.The reason of this event cannot be determined.Batch review performed on 24 september 2018: lot 134523: 60 items manufactured and released on 15 november 2013.Expiration date: 2022-09-24.No anomalies found related to the problem.To date, 58 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Information received on 27 august 2018: patient underwent primary surgery successfully in 2014.Patient returned to surgeon this month with pain, x-ray showed cup had flipped.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 46
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7909557
• Report Number: 3005180920-2018-00719
• Device Sequence Number: 1346443
• Product Code: LZO
• UDI-Device Identifier: 07630030807749
• UDI-Public: 07630030807749
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2022
• Device Catalogue Number: 01.26.45.0046
• Device Lot Number: 134523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR