MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 50 NO-HOLE; ACETABULAR CUP

Model Number	01.32.150SH
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19.Feb.2021: lot 165747: (b)(4) items manufactured and released on 21-dec-2016.Expiration date: 2021-12-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.
Event or Problem Description
The patient came in 9 months after the primary surgery reporting pain due to cup impingement with the soft tissue.The cup was in a suboptimal position since the primary surgery.The surgeon revised the cup, head and liner and added a sleeve.The surgery was completed successfully.The only reason the head was revised is because it needed to be downsized to fit dual mobility.

• Brand Name: CUP: MPACT ACETABULAR SHELL 50 NO-HOLE
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11411809
• Report Number: 3005180920-2021-00177
• Device Sequence Number: 4461468
• Product Code: LPH
• UDI-Device Identifier: 07630030810787
• UDI-Public: 07630030810787
• 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): 03/04/2021

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: 12/11/2021
• Device Model Number: 01.32.150SH
• Device Catalogue Number: 01.32.150SH
• Device Lot Number: 165747
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2021
• Initial Report FDA Received Date: 03/04/2021
• 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