MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 32 / E; ACETABULAR PE LINER

Model Number	01.26.3244HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 march 2021: lot 2007564: (b)(4) items manufactured and released on 13-oct-2020.Expiration date: 2025-09-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.2006685.Batch review performed on 08 march 2021: lot 2006685: (b)(4) items manufactured and released on 14-oct-2020.Expiration date: 2025-09-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: hip dislocation 1 month after primary implantation.This event probably occurred during rehabilitation.Hip dislocation may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.
Event or Problem Description
Revision surgery due to dislocation of the head from the liner 1 month after the primary.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 32 / E
• Common Device Name: ACETABULAR PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11463080
• Report Number: 3005180920-2021-00184
• Device Sequence Number: 4189986
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• 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): 03/11/2021

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: 09/27/2025
• Device Model Number: 01.26.3244HCT
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 2007564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/11/2021
• 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
• Patient Age: 68 YR
• Patient Weight: 105