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

Model Number	01.32.3244HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12.Mar.2021: lot 186966: (b)(4) items manufactured and released on 19-oct-2018.Expiration date: 2023-10-01.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.Additional implant involved: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.2006687.Batch review performed on 12.Mar.2021: lot 2006687: (b)(4) items manufactured and released on 1-oct-2020.Expiration date: 2025-09-17.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.
Event or Problem Description
The patient came in 1 month and 3 days after the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER 32/E
• Common Device Name: ACETABULAR PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11580775
• Report Number: 3005180920-2021-00245
• Device Sequence Number: 4157532
• Product Code: LPH
• UDI-Device Identifier: 07630030811913
• UDI-Public: 07630030811913
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 10/01/2023
• Device Model Number: 01.32.3244HCT
• Device Catalogue Number: 01.32.3244HCT
• Device Lot Number: 186966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/29/2021
• 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: 61 YR