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

Catalog Number	01.26.3644HCT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 september 2019.Lot 172716: (b)(4) items manufactured and released on 05-sep-2017.Expiration date: 2022-08-18.No anomalies found.
Event or Problem Description
Revision surgery where the surgeon wants to change the liner to a hooded one.At the moment no more informations are available concerning the surgery date and the outcomes.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / 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: 8964553
• Report Number: 3005180920-2019-00752
• Device Sequence Number: 16682127
• Product Code: LZO
• UDI-Device Identifier: 07630030807671
• UDI-Public: 07630030807671
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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: 08/18/2022
• Device Catalogue Number: 01.26.3644HCT
• Device Lot Number: 172716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 09/05/2019
• 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