MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT HOODED PE HC LINER Ø32/D; HIP SHELL LINER

Model Number	01.32.3241HCAT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02-jun-2023: lot 2103119: (b)(4) items manufactured and released on 26-may-2021.Expiration date: 2026-05-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2019.On (b)(6) 2021, the patient came in reporting pain due to a loose stem and the cause of the loose stem was unknown.The surgeon revised successfully the medacta stem and head with competitor components and revised the medacta liner with a medacta liner.Presently, on (b)(6) 2023, the patient came in reporting pain due to a dislocation and the cause is unknown.The surgeon revised successfully the cup, liner and compethitor head.

• Brand Name: MPACT HOODED PE HC LINER Ø32/D
• 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: 17216772
• Report Number: 3005180920-2023-00456
• Device Sequence Number: 15006179
• Product Code: LPH
• UDI-Device Identifier: 07630030811869
• UDI-Public: 07630030811869
• 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: 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): 06/28/2023

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: 05/06/2026
• Device Model Number: 01.32.3241HCAT
• Device Catalogue Number: 01.32.3241HCAT
• Device Lot Number: 2103119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2026
• 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