MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 40/G; ACETABULAR PE HC LINER

Model Number	01.32.4052HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 july 2021: lot 1900227: (b)(4) items manufactured and released on 17-apr-2019.Expiration date: 2024-04-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a similar reported event.Additional implant involved: ball heads: mectacer 01.29.213 biolox delta ceramic ball head 12/14 ø 40 size m 0 (k112115) lot.1907365.Batch review performed on 02 july 2021: lot 1907365: (b)(4) items manufactured and released on 27-jan-2020.Expiration date: 2025-01-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: cup: mpact 01.32.160dh acetabular shell ø60 two-holes (k132879) lot.1904329.Batch review performed on 02 july 2021: ¨lot 1904329: (b)(4) items manufactured and released on 27-aug-2019.Expiration date: 2024-08-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.About 11 months after primary the surgeon performed a washout and revised the cup, head, and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER 40/G
• Common Device Name: ACETABULAR PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12148668
• Report Number: 3005180920-2021-00588
• Device Sequence Number: 17368003
• Product Code: LZO
• UDI-Device Identifier: 07630030812286
• UDI-Public: 07630030812286
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/12/2021

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: 04/06/2024
• Device Model Number: 01.32.4052HCT
• Device Catalogue Number: 01.32.4052HCT
• Device Lot Number: 1900227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/12/2021
• 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