MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO FLAT PE HC 32 / C; CEMENTLESS LINER PE HC

Model Number	01.26.3239HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery planned for hip infection.No further information is available at 14 april 2021.A liner and head substitution have been requested by the hospital for this revision.It is unknown if the head to be revised is medacta product or not.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC 32 / C
• Common Device Name: CEMENTLESS LINER PE HC
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11664354
• Report Number: 3005180920-2021-00286
• Device Sequence Number: 11508279
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/14/2021

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 Model Number: 01.26.3239HCT
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/14/2021
• 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