MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø36/G; FACE-CHANGING PE HC LINER

Model Number	01.32.3652HC10A
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 may 2022.Lot 1810852: (b)(4) items manufactured and released on 28-mar-2019.Expiration date: 2024-mar-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional items involved in the event, batch review performed on 24 may 2022.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot.2012925.Lot 2012925: (b)(4) items manufactured and released on 15-apr-2021.Expiration date: 2026-mar-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Stem: amistem p 01.18.408 amistem-p std stem size 8 (k173794) lot.179943.Lot 179943: (b)(4) items manufactured and released on 08-may-2018.Expiration date: 2023-apr-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Cup: mpact 01.32.160dh acetabular shell ø60 two-holes (k132879) lot.2001289.Lot 2001289: (b)(4) items manufactured and released on 01-jul-2020.Expiration date: 2025-jun-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2020.On (b)(6) 2021, the patient came in reporting pain due to a dislocation of the head from the liner.The surgeon revised the head and liner.Presently, on (b)(6) 2022, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø36/G
• Common Device Name: FACE-CHANGING PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14684583
• Report Number: 3005180920-2022-00463
• Device Sequence Number: 17837251
• Product Code: LPH
• UDI-Device Identifier: 07630040731119
• UDI-Public: 07630040731119
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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: 03/13/2024
• Device Model Number: 01.32.3652HC10A
• Device Catalogue Number: 01.32.3652HC10A
• Device Lot Number: 1810852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male