MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C

Model Number	01.26.3239HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components, and implanted an antibiotic spacer 3 months and a half after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 2101759: 135 items manufactured and released on (b)(6) 2021.Expiration date: (b)(6) 2026.No anomalies found related to the problem.To date, 125 items of the same lot have been already sold without any similar reported event.Additional implant involved: batch review performed on (b)(6) 2022.Versafitcup cc trio 01.26.45.0046 acetabular shell cc trio ø 48 (k103352); lot 2101345: 150 items manufactured and released on (b)(6) 2021.Expiration date: (b)(6) 2026.No anomalies found related to the problem.To date, 106 items of the same lot have been already sold without any similar reported event.Sms solid 01.36.046 sms solid stem std size 6 (k181693); lot 2000852: 20 items manufactured and released on (b)(6) 2020.Expiration date: (b)(6) 2025.No anomalies found related to the problem.To date, 17 items of the same lot have been already sold without any similar reported event.Mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115); lot 2012911: 400 items manufactured and released on (b)(6) 2021.Expiration date: (b)(6) 2026.No anomalies found related to the problem.To date, 314 items of the same lot have been already sold without any similar reported event.

• Brand Name: VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C
• Common Device Name: FLAT PE HC LINER
• 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: 13515072
• Report Number: 3005180920-2022-00096
• Device Sequence Number: 19873303
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 02/11/2022

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: 03/17/2026
• Device Model Number: 01.26.3239HCT
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 2101759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2021
• 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: Female