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

Model Number	01.26.3644HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 march 2021: lot 2008266: 273 items manufactured and released on 13-oct-2020.Expiration date: 2025-09-24.No anomalies found related to the problem.To date, 232 items of the same lot have been already sold without any other similar reported event.Clinial evaluation performed by medacta medical affairs department: few weeks after the primary cementless tha an infection is suspected, therefore open irrigation and cleaning is performed and, as customary, head and insert are exchanged.This reoperation was not caused by device inefficiency.Another device involved: batch review performed on 15 march 2021: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115)lot.2002608: 473 items manufactured and released on 03-aug-2020.Expiration date: 2025-07-21.No anomalies found related to the problem.To date, 390 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery 8 weeks after the primary due to suspected infection.Dair was performed.The insert and head were successfully revised.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC 36 / E
• Common Device Name: ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11626180
• Report Number: 3005180920-2021-00263
• Device Sequence Number: 3499248
• Product Code: LZO
• UDI-Device Identifier: 07630030807671
• UDI-Public: 07630030807671
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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 Expiration Date: 09/24/2025
• Device Model Number: 01.26.3644HCT
• Device Catalogue Number: 01.26.3644HCT
• Device Lot Number: 2008266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/07/2021
• 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
• Patient Age: 70 YR
• Patient Weight: 100