MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28; HIP DOUBLE MOBILITY HC LINER

Model Number	01.26.2852MHC
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 february 2023: lot 2009653: (b)(4) items manufactured and released on 18-mar-2021.Expiration date: 2015-11-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with other 2 similar reported events in the period of review.Other devices involved: liner: mpact 01.32.4452mc dm converter liner g/dmf ((b)(4)) lot 2010075: (b)(4) items manufactured and released on 11-nov-2020.Expiration date: 2025-11-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 ((b)(4)) lot 2007621: (b)(4) items manufactured and released on 30-oct-2020.Expiration date: 2025-10-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
Revision surgery for infection 1 year and 10 months post primary for infection.Liners and head revised successfully.

• Brand Name: LINER: MPACT DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28
• Common Device Name: HIP DOUBLE MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16520701
• Report Number: 3005180920-2023-00150
• Device Sequence Number: 11386049
• Product Code: MEH
• UDI-Device Identifier: 07630030807343
• UDI-Public: 07630030807343
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 03/10/2023

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: 11/08/2015
• Device Model Number: 01.26.2852MHC
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 2009653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2021
• 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