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

Model Number	01.26.3239HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 aug 2021: lot 2001444: (b)(4) items manufactured and released on 18-jun-2020.Expiration date: 2025-05-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Other devices involved: batch review performed on 02 aug 2021: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 lot.2006686 (k112115): (b)(4) items manufactured and released on 05-oct-2020.Expiration date: 2025-09-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of an infection (pathogen is unknown).The surgeon performed a washout and revised the head and liner 4 months and a half after the primary surgery.The surgery was completed successfully.

• Brand Name: VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER DIAM 32 / C
• Common Device Name: HIP LINER FLAT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12364717
• Report Number: 3005180920-2021-00675
• Device Sequence Number: 3974197
• 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: 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): 08/25/2021

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: 05/06/2025
• Device Model Number: 01.26.3239HCT
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 2001444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/25/2021
• 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