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

Model Number	01.26.3248HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22.Jan.2020: lot 155387: (b)(4) items manufactured and released on 14.12.2015.Expiration date: 2020-11-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
Revision surgery planned after 3 years and 9 months from the primary due to an infection.The surgeon plans to revise the liner.
Additional Manufacturer Narrative
Revision surgery performed on (b)(6) 2020, 3 years and 9 months from the primary due to an infection.The surgeon revised the liner.
Event or Problem Description
Revision surgery performed after 3 years and 9 months from the primary due to an infection.The surgeon revised the liner.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER 32 / F
• Common Device Name: ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9706056
• Report Number: 3005180920-2020-00048
• Device Sequence Number: 3675614
• Product Code: LZO
• UDI-Device Identifier: 07630030807619
• UDI-Public: 07630030807619
• 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 Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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 Expiration Date: 11/21/2020
• Device Model Number: 01.26.3248HCT
• Device Catalogue Number: 01.26.3248HCT
• Device Lot Number: 155387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/11/2020
• 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