MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT OFFSET 4MM PE HC LINER Ø40/F; HIP SHELL LINER

Catalog Number	01.32.4048HC4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 octber 2023: lot 2215935: (b)(4) items manufactured and released on 04-aug-2022.Expiration date: 2027-07-24.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) 2022.On (b)(6) 2023, the patient came in reporting pain and instability due to a distally potted stem.The surgeon revised the medacta stem and head with competitor implants and revised the medacta liner with a medacta liner.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in reporting pain after sustaining a dislocation of the head from the liner and the cause is unknown.The surgeon revised the competitor head and medacta liner and the surgery was completed successfully.

• Brand Name: MPACT OFFSET 4MM PE HC LINER Ø40/F
• Common Device Name: HIP SHELL 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: 18109176
• Report Number: 3005180920-2023-00861
• Device Sequence Number: 7891403
• Product Code: LPH
• UDI-Device Identifier: 07630040731256
• UDI-Public: 07630040731256
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• 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: 01.32.4048HC4
• Device Lot Number: 2215935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2022
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Race: White