MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58; HIP CEMENTLESS CUP

Model Number	01.26.45.0058
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 february 2022: lot 2109131: (b)(4) items manufactured and released on 13-oct-2021.Expiration date: 2026-sep-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation: revision of a total hip replacement in a (b)(6) patient 2 months after the primary surgery.From the radiographic image provided it is visible that the acetabular cup migrated through the medial acetabular wall.According to the report, the patient didn't follow the instructions and he put full weight on the operated leg.This is probably the reason of this adverse event.No reason to suspect that this event is due to a faulty device.
Event or Problem Description
The patient didn't follow the doc's post-op instructions of partial weight-bearing.He put full weight on the leg and the acetabular wall broke (bone), 2 months after primary surgery.No damage to the implants.The femoral stem was tight, with no signs of loosening.Cup, liner, and head revised.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58
• Common Device Name: HIP CEMENTLESS CUP
• 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: 13769971
• Report Number: 3005180920-2022-00175
• Device Sequence Number: 19788971
• Product Code: LZO
• UDI-Device Identifier: 07630030807800
• UDI-Public: 07630030807800
• 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 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): 03/15/2022

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: 09/29/2026
• Device Model Number: 01.26.45.0058
• Device Catalogue Number: 01.26.45.0058
• Device Lot Number: 2109131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2021
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 79 KG