MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 50

Model Number	01.26.50MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 august 2020: lot 1906132: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-22.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.Additional items involved in the event, batch review performed on 21 august 2020: stem: amistem p 01.18.402 amistem-p std stem size 2 lot.1904135 lot 1904135: (b)(4) items manufactured and released on 05-sep-2019.Expiration date: 2024-08-20.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 ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 lot.183338.Lot 183338: (b)(4) items manufactured and released on 03-oct-2018.Expiration date: 2023-09-23.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 liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 lot.1906159.Lot 1906159: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-03.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.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.2 months after primary the surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL 50
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10513712
• Report Number: 3005180920-2020-00589
• Device Sequence Number: 3538771
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: 02/22/2025
• Device Model Number: 01.26.50MB
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 1906132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/10/2020
• 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