MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE; CEMENTLESS ACETABULAR CUP

Model Number	01.32.156MH
Medical Device Problem Code	Osseointegration Problem (3003)
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 15 february 2021: lot 183913: (b)(4) items manufactured and released on 11-july-2018.Expiration date: 2023-07-03.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
The patient came in reporting pain 2 years 4 months after the primary and the cause of the pain is unknown.The surgeon revised the cup, head, and liner and added a sleeve.No osteointegration was found on the cup upon its removal.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11451536
• Report Number: 3005180920-2021-00180
• Device Sequence Number: 17156031
• Product Code: LPH
• UDI-Device Identifier: 07630030810862
• UDI-Public: 07630030810862
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 03/10/2021

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: 07/03/2023
• Device Model Number: 01.32.156MH
• Device Catalogue Number: 01.32.156MH
• Device Lot Number: 183913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/10/2021
• 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