MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 36 / E; HIP SHELL LINER

Model Number	01.26.3644HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 november 2021: lot 1810756: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-02-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without similar reported event.Clinical evaluation performed by medacta medical affairs manager: hip dislocation occurred few weeks after first revision due to traumatic periprosthetic femoral fracture.Hip dislocation may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.Additional device involved: implant from ceramtec 38.49.7175.925.00 biolox delta ceramic ball head 12/14 ø 36 size xl +8 lot.7011119013 - not marketed in the usa.
Event or Problem Description
At 2 years and 6 months after the primary surgery.The hip of the patient luxated (liner-head).The patient is not healthy and lives in a care home, the circumstances and date of the luxation is unknown, it was noticed about 1 week later and therefore the exact cause of the luxation is unknown.This is the second revision for this patient.Previously this patient has a stem revision due to a periprosthetic femoral fracture caused by a fall.

• Brand Name: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 36 / E
• Common Device Name: HIP SHELL 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: 12852076
• Report Number: 3005180920-2021-00898
• Device Sequence Number: 4317259
• Product Code: LZO
• UDI-Device Identifier: 07630030807671
• UDI-Public: 07630030807671
• 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: 2019
• 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): 11/22/2021

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: 02/18/2024
• Device Model Number: 01.26.3644HCT
• Device Catalogue Number: 01.26.3644HCT
• Device Lot Number: 1810756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2019
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White