MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC ACETABULAR SHELL CC TRIO Ø 56

Model Number	01.26.45.0056
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 january 2020: lot 181700: (b)(4) items manufactured and released on 20-june-2018.Expiration date: 2023-06-11.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 since 1-1-2016.Additional items involved in the complaint, batch review performed on 23 january 2020 liner: cc e cc light 01.26.3648hct flat pe hc liner ø 36 / f lot.187921 lot 187921: (b)(4) items manufactured and released on 28-nov-2018.Expiration date: 2023-11-09.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.Stem: amistem c 01.18.436 amistem-p collared std stem #6 lot.1901536 lot 1901536: (b)(4) items manufactured and released on 25-may-2019.Expiration date: 2024-05-07.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 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 lot.1903863 lot 1903863: (b)(4) items manufactured and released on 26-july-2019.Expiration date: 2024-07-15.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.About a month after primary the surgeon removed all implants and implanted new components.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP CC ACETABULAR SHELL CC TRIO Ø 56
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9698516
• Report Number: 3005180920-2020-00042
• Device Sequence Number: 2898119
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 06/11/2023
• Device Model Number: 01.26.45.0056
• Device Catalogue Number: 01.26.45.0056
• Device Lot Number: 181700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/12/2020
• 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