MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 28/B; ACETABULAR PE HC LINER

Model Number	01.32.2837HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 june 2021: lot 163983: (b)(4) items manufactured and released on 29-jul-2016.Expiration date: 2021-07-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event since 2017.Additional implant involved: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.1907337: batch review performed on 14 june 2021: lot1907337: (b)(4) items manufactured and released on 22-jan-2020.Expiration date: 2024-12-16.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
3 weeks 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 poly.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER 28/B
• Common Device Name: ACETABULAR PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12091121
• Report Number: 3005180920-2021-00543
• Device Sequence Number: 3926242
• Product Code: LPH
• UDI-Device Identifier: 07630030811531
• UDI-Public: 07630030811531
• 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): 06/30/2021

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: 07/10/2021
• Device Model Number: 01.32.2837HCT
• Device Catalogue Number: 01.32.2837HCT
• Device Lot Number: 163983
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/30/2021
• 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