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

Model Number	01.32.4052HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 june 2021: lot 2009617: (b)(4) items manufactured and released on 28-oct-2020.Expiration date: 2025-10-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without another similar reported event.Other devices involved: batch review performed on 22 june 2021: ball heads: mectacer 01.29.233h head biolox option ø 40 (k131518) lot 176860: (b)(4) items manufactured and released on 16-apr-2018.Expiration date: 2024-04-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Ball heads: mectacer 01.29.242a sleeve size l (k131518) lot 19c0072: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-11-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Cup: mpact 01.32.160dh acetabular shell ø60 two-holes (k132879) 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 without any similar reported event.Stem: masterloc 01.39.209 cementless ti coated lat stem size 9 (k151531)lot 1908741: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.1 month after primary on (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC 40/G
• Common Device Name: ACETABULAR LINER PE HC
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12134401
• Report Number: 3005180920-2021-00552
• Device Sequence Number: 3704698
• Product Code: LZO
• UDI-Device Identifier: 07630030812286
• UDI-Public: 07630030812286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122641
• 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): 07/08/2021

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: 10/18/2025
• Device Model Number: 01.32.4052HCT
• Device Catalogue Number: 01.32.4052HCT
• Device Lot Number: 2009617
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 07/08/2021
• 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