MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT HOODED PE HC LINER Ø36/E; HIP SHELL LINER

Model Number	01.32.3644HCAT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 november 2021: lot 2004193: (b)(4) items manufactured and released on 11-08-2020.Expiration date: 2025-07-12.No anomalies were found related to the problem.To date, all items of the same lot have been sold without similar reported event.Additional device involved: batch review performed on 23 november 2021: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot 2009402: (b)(4) items manufactured and released on 26-01-2021.Expiration date: 2026-01-14.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.
Event or Problem Description
The patient came in 1 month after the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner and the surgery was completed successfully.

• Brand Name: MPACT HOODED PE HC LINER Ø36/E
• Common Device Name: HIP SHELL 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: 12974380
• Report Number: 3005180920-2021-00972
• Device Sequence Number: 20054562
• Product Code: LPH
• UDI-Device Identifier: 07630030812101
• UDI-Public: 07630030812101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• 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): 12/10/2021

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: 07/12/2025
• Device Model Number: 01.32.3644HCAT
• Device Catalogue Number: 01.32.3644HCAT
• Device Lot Number: 2004193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2020
• 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: Female