MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52; HIP DOUBLE MOBILITY ACETABULAR CUP

Model Number	01.32.152MB
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 january 2022.Lot 2104479: (b)(4) items manufactured and released on 02-sep-2021.Expiration date: 2026-aug-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
After the primary hip surgery, when the patient was in recovery, it was observed on x-rays that the cup had moved due to poor bone quality.The surgeon brought the patient back into surgery and revised the cup, head, and liner the same day of primary.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52
• Common Device Name: HIP DOUBLE MOBILITY ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13523869
• Report Number: 3005180920-2022-00109
• Device Sequence Number: 12086949
• Product Code: LPH
• UDI-Device Identifier: 07630030860973
• UDI-Public: 07630030860973
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/14/2022

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: 08/22/2026
• Device Model Number: 01.32.152MB
• Device Catalogue Number: 01.32.152MB
• Device Lot Number: 2104479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2021
• 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: Male