MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48

Catalog Number	01.26.45.0048
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 may 2019: lot 173463: (b)(4) items manufactured and released on 26-set-2017.Expiration date: 2022-09-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: hip revision surgery performed 1,5 years after primary hybrid total hip arthroplasty in a (b)(6) year old woman.Poor quality of the image provided does not allow a proper evaluation of the cement mantle and radiotransparent zones.The reason of this event cannot be determined.Additional implant involved in the event, batch review performed on 22 may 2019: stem: amistem c 01.18.152 cemented std stem size 2 lot.176514 (k103189): (b)(4) items manufactured and released on 28-nov-2017.Expiration date: 2022-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed after 1 year and 5 months from the primary due to radiolucencies (stem + acetabulum) and stem loosening.The cup, liner, ball head and stem have been revised.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8821370
• Report Number: 3005180920-2019-00599
• Device Sequence Number: 19454106
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/24/2019

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: 09/17/2022
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 173463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/24/2019
• 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: 79 YR
• Patient Weight: 75