MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO 01.26.3644HCT FLAT PE HC LINER Ø 36 / E; HIP FLAT PE HC LINER

Catalog Number	01.26.3644HCT
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-apr-2024 lot 2118278: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2026-12-22.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Other component involved (not registered in us): implants from ceramtec 38.49.7175.925.00 biolox delta ceramic ball head 12/14 ø 36 size xl +8 lot.7011170104.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect or non-conformities regarding sterilisation.Due to the fact that the femoral head at issue was not provided, it is not possible to carry out any further investigations.During the management and analysis of the complaint mdr (b)(4) related to the stem breakage, we found that the intermediate revisions had not been previously notified and for this reason these revisions has been notified today.
Event or Problem Description
At about 8 days after primary, the patient has been revised because of surgical wound issues.In details, serous secretions from the wound were noted.Mobile components of the prosthesis have been revised successfully.

• Brand Name: LINER: VERSAFITCUP CC TRIO 01.26.3644HCT FLAT PE HC LINER Ø 36 / E
• Common Device Name: HIP FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19266722
• Report Number: 3005180920-2024-00304
• Device Sequence Number: 6981603
• 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: 2022
• 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): 05/08/2024

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 Catalogue Number: 01.26.3644HCT
• Device Lot Number: 2118278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2022
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 115 KG