MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 52 MULTI-HOLE; ACETABULAR SHELL

Model Number	01.32.152MH
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 april 2021: lot 1900203: (b)(4) items manufactured and released on 13-june-2019.Expiration date: 2024-05-29.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
Primary performed in (b)(6) 2021.Post-op x-rays revealed a malpositioned cup.In (b)(6) 2021 the surgeon successfully revised the cup, liner, and head.

• Brand Name: CUP: MPACT 52 MULTI-HOLE
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11854201
• Report Number: 3005180920-2021-00404
• Device Sequence Number: 11572482
• Product Code: LPH
• UDI-Device Identifier: 07630030810800
• UDI-Public: 07630030810800
• 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: 2021
• 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): 05/20/2021

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: 05/29/2024
• Device Model Number: 01.32.152MH
• Device Catalogue Number: 01.29.209
• Device Lot Number: 2005405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/20/2021
• 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