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

Model Number	01.26.45.0048
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery 1 year and 3 months after the primary due to infection.The surgeon removed all implants and washed the area.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26 november 2021: lot 1910234: (b)(4) items manufactured and released on 31-march-2020.Expiration date: 2025-03-16.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Clinical evaluation: delayed infection in cementless tha, 1.3 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Preliminary investigation: based on the pictures available no evaluation can be performed and no definitive root cause can be established.Another devices involved: batch review performed on 26 november 2021: stem: amistem p 01.18.402 amistem-p std stem size 2 (k173794) lot 1910405: (b)(4) items manufactured and released on 31-mar-2020.Expiration date: 2025-03-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot 1906466: (b)(4) items manufactured and released on 30-ott-2019.Expiration date: 2024-10-16.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Liner: mectacer 01.29.408 ceramic liner (not registred in usa)lot 1909006: (b)(4) items manufactured and released on 17-feb-2020.Expiration date: 2025-02-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12982794
• Report Number: 3005180920-2021-00977
• Device Sequence Number: 17468243
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 12/13/2021

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: 03/16/2025
• Device Model Number: 01.26.45.0048
• Device Catalogue Number: 01.26.45.004
• Device Lot Number: 1910234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male