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

Model Number	01.26.3644HCT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-jul-2022: lot 2109522: 130 items manufactured and released on 06-sep-2021.Expiration date: 2026-08-22.No anomalies found related to the problem.To date, 125 items of the same lot have been sold with no similar reported case during the period of.
Event or Problem Description
Revision surgery performed at about 2 weeks after the primary surgery due to hip luxation.Head and liner were successfully revised for a double mobility converter.

• Brand Name: LINER: CC E CC LIGHT 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: 15154692
• Report Number: 3005180920-2022-00583
• Device Sequence Number: 20142469
• 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): 08/03/2022

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: 08/22/2026
• Device Model Number: 01.26.3644HCT
• Device Catalogue Number: 01.26.3644HCT
• Device Lot Number: 2109522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Hispanic
• Patient Race: White