MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 36/F; ACETABULAR PE HC LINER

Model Number	01.32.3648HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 05.Oct.2021: lot 2100161: (b)(4) items manufactured and released on 5-feb-2021.Expiration date: 2026-01-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Additional implant involved: ball heads: mectacer 01.29.211 biolox delta ceramic ball head 12/14 ø 36 size xl + (k112115) lot.177710.Batch reviews performed on 05.Oct.2021: lot 177710: (b)(4) items manufactured and released on 27-feb-2018.Expiration date: 2023-02-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.
Event or Problem Description
About 1 month after the primary surgery the patient came in 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 36/F
• Common Device Name: ACETABULAR PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12687963
• Report Number: 3005180920-2021-00829
• Device Sequence Number: 11803627
• Product Code: LPH
• UDI-Device Identifier: 07630030812132
• UDI-Public: 07630030812132
• Combination Product (Y/N): N
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2021

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: 01/21/2026
• Device Model Number: 01.32.3648HCT
• Device Catalogue Number: 01.32.3648HCT
• Device Lot Number: 2100161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/25/2021
• 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