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

Model Number	01.32.3652HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06.Oct.2021: lot 188511: (b)(4) items manufactured and released on 7-dec-2018.Expiration date: 2023-11-14.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 item related to the event, batch review performed on 06 october 2021.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot.1908997.Lot 1908997: (b)(4) items manufactured and released on 4-feb-2020.Expiration date: 2025-01-19.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
At 1 year and 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/G
• Common Device Name: LINER FLAT PE HC
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12712167
• Report Number: 3005180920-2021-00831
• Device Sequence Number: 14698734
• Product Code: LPH
• UDI-Device Identifier: 07630030812156
• UDI-Public: 07630030812156
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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: 11/14/2023
• Device Model Number: 01.32.3652HCT
• Device Catalogue Number: 01.32.3652HCT
• Device Lot Number: 188511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/28/2021
• 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