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

Model Number	01.26.3644HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 january 2022.Lot 2007567: (b)(4) items manufactured and released on 13-oct-2020.Expiration date: 2025-sep-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional implant involved: ball heads: cocr 01.25.030 cocr ball head 12/14 ø 36 size s -3.5 (k080885) lot.1901510.Batch review performed on 12 january 2022.Lot 1901510: (b)(4) items manufactured and released on 08-jul-2019.Expiration date: 2024-jun-19.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 performed by medical affairs manager.Delayed infection in cemented tha, 1 year after first revision surgery.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
At 1 year after the primary surgery, the surgeon revised the liner and head due to infection.Double mobility implanted.The patient previously underwent revision surgery 3 days after the primary surgery due to periprosthetic fracture caused by a trauma.Only stem revised.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / E
• Common Device Name: ACETABULAR PE HC 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: 13383495
• Report Number: 3005180920-2022-00050
• Device Sequence Number: 11629356
• 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: 2020
• 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): 01/28/2022

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: 09/27/2025
• Device Model Number: 01.26.3644HCT
• Device Catalogue Number: 01.26.3644HCT
• Device Lot Number: 2007567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2020
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White