MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER 32 / E

Model Number	01.26.3244HCAT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery is performed on (b)(6) 2020 (primary date unknown) due to an infection (the pathogen is unknown).The surgeon revised the liner, head and cup but at this moment the lot numbers are unknown and probably more information will not be available.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER 32 / E
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11026227
• Report Number: 3005180920-2020-00918
• Device Sequence Number: 668603
• Product Code: LZO
• UDI-Device Identifier: 07630030807565
• UDI-Public: 07630030807565
• 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 Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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 Model Number: 01.26.3244HCAT
• Device Catalogue Number: 01.26.3244HCAT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention