MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 54 NO-HOLE; CEMENTLESS ACETABULAR CUP

Model Number	01.32.154SH
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04.June.2021: lot 2000214: (b)(4) items manufactured and released on 11-may-2020.Expiration date: 2025-04-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
9 months after the primary surgery the patient came in reporting pain due to iliopsoas tendon and cup impingement and the cause of the iliopsoas impingement is unknown.The surgeon revised the cup, head, and liner.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL 54 NO-HOLE
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12038731
• Report Number: 3005180920-2021-00506
• Device Sequence Number: 4094203
• Product Code: LPH
• UDI-Device Identifier: 07630030810848
• UDI-Public: 07630030810848
• 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: 2020
• 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): 06/22/2021

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: 04/23/2025
• Device Model Number: 01.32.154SH
• Device Catalogue Number: 01.32.154SH
• Device Lot Number: 2000214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention