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

Model Number	01.26.45.0056
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The primary surgery took place in 2020 (the exact date is unknown).Revision surgery performed on (b)(6) 2021 because of a low-grade infection and osteoporosis.All implants revised.
Additional Manufacturer Narrative
Batch review performed on 23 november 2021.Lot 1901423: (b)(4).Expiration date: 2024-may-25.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.Clinical evaluation: infection in cementless tha.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.Another devices involved: batch review performed on 23 november 2021: liner: mectacer 01.29.414 ceramic liner ø 36 / f (not registered in usa) lot 1904667: (b)(4).Expiration date: 2024-aug-31.No anomalies found related to the problem.(b)(4).Stem: amistem p 01.18.415 amistem-p lat stem size 5 (k173794)lot 1904149: (b)(4).Expiration date: 2024-jul-24.No anomalies found related to the problem.(b)(4).Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 1903861: (b)(4).Expiration date: 2024-jul-17.No anomalies found related to the problem.(b)(4).

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56
• 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: 12998610
• Report Number: 3005180920-2021-00976
• Device Sequence Number: 5656627
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/14/2021

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: 05/25/2024
• Device Model Number: 01.26.45.0056
• Device Catalogue Number: 01.26.45.0056
• Device Lot Number: 1901423
• 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: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2019
• 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 Sex: Male