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

Catalog Number	01.26.45.0050
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on december the 02nd 2019: lot 161593: 120 items manufactured and released on 20-jun-2016.Expiration date: 06.06.2021.No anomalies found related to the problem, to date, all items of the same lot have been already sold without any other similar reported event.Manufacturer process review: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilisation.Due to lack of ceramic parts no further investigation can be done.
Event or Problem Description
Revision surgery performed due to infection 3 years after the primary surgery.On the (b)(6) 2017 the patient has been revised (head) due to hip dislocation, caused by trauma.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50
• Common Device Name: ACETABULAR HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9416244
• Report Number: 3005180920-2019-01045
• Device Sequence Number: 16766885
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 05/12/2019

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: 06/06/2021
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 161593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/05/2019
• 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
• Patient Age: 49 YR
• Patient Weight: 90