MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT 01.26.2244MHC DOUBLE MOBILITY HC LINER 22.2/DMB; HIP DOUBLE MOBILITY HC LINER

Catalog Number	01.26.2244MHC
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 october 2023.Lot 2206939: (b)(4) items manufactured and released on 11-may-2022.Expiration date: 2027-04-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involved: liner: mpact 01.32.3641cf dm converter tin coated d/dmb (k211891) lot 2110381: (b)(4) items manufactured and released on 06-dec-2021.Expiration date: 2026-11-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Ball heads: cocr 01.25.124 cocr ball head 12/14 ø 22 size s -2,5 (k080885) lot 1901497: (b)(4) items manufactured and released on 18-jun-2019.Expiration date: 2024-06-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2023.On (b)(6) 2023, the patient came in reporting pain due to a dislocation of the head from the liner that the patient sustained while dancing.The surgeon revised the head and liner and the surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT 01.26.2244MHC DOUBLE MOBILITY HC LINER 22.2/DMB
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18111194
• Report Number: 3005180920-2023-00863
• Device Sequence Number: 7891568
• Product Code: LZO
• UDI-Device Identifier: 07630030806803
• UDI-Public: 07630030806803
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 11/10/2023

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 Catalogue Number: 01.26.2244MHC
• Device Lot Number: 2206939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2022
• 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