MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 50; HIP ACETABULAR SHELL

Catalog Number	01.26.45.0050
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department acetabular component revision performed 5 years and 10 months after cementless total hip arthroplasty.No information concerning patient age, general health status and comorbidities is available.Aseptic loosening is a possible literature described adverse event after cementless thr and causes are often unknown.The reason of this event cannot be determined.Batch review performed on 08-august-2019 lot 131667: (b)(4) items manufactured and released on 02-aug-2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold with another similar reported event.
Event or Problem Description
The patient presented with pain, and looking at their x-ray it can clearly been seen that the cup has rolled over.The patient requires revision surgery.The reason for revision is acetabular loosening.The surgeon revised cup, liner and head 5 years and 10 months after primary.The surgery was completed successfully.We were informed about the event on (b)(6).The revision surgery was performed on (b)(6).

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 50
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8955163
• Report Number: 3005180920-2019-00729
• Device Sequence Number: 11415535
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• 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: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2019

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: 06/30/2018
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 131667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 09/03/2019
• 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