MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO 01.26.45.0048 ACETABULAR SHELL CC TRIO DIAM 48; HIP ACETABULAR SHELL

Model Number	01.26.45.0048
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Subluxation (4525)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 august 2021: lot 2007993: (b)(4) items manufactured and released on 19-nov-2020.Expiration date: 2025-nov-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs manager: hip dislocation 4 months after primary implantation.A femoral revision was performed few weeks after primary surgery due to periprosthetic fracture.Hip dislocation may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.Other devices involved: batch review performed on 13 september 2021: stem: amistem p 01.18.401 amistem-p std stem #1 (k173794) lot 2005833: (b)(4) items manufactured and released on 01-oct-2020.Expiration date: 2025-sept-21.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 had primary surgery on (b)(6) 2021.The patient had first revision surgery due to bone fracture on (b)(6) 2021.The fracture was caused by patient's fall.Only amistem-p stem and cocr head were revised.M-vizion stem and new cocr head implanted.On (b)(6) 2021 luxation occurred due to too much anteversion of the cup.Cup, head, and liner were revised.

• Brand Name: CUP: VERSAFITCUP CC TRIO 01.26.45.0048 ACETABULAR SHELL CC TRIO DIAM 48
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12474791
• Report Number: 3005180920-2021-00731
• Device Sequence Number: 3939469
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• 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): 09/15/2021

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: 11/08/2025
• Device Model Number: 01.26.45.0048
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 2007993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/15/2021
• 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