MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48; DOUBLE MOBILITY CUP

Model Number	01.32.148MB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
After the primary hip surgery, in post-op recovery when x-rays were taken, it was observed that the cup has not correctly seated.The surgeon decided to revise all components.
Additional Manufacturer Narrative
Batch review performed on 09-jun-2023.Lot 2218079: (b)(4) items manufactured and released on 17-jan-2023.Expiration date: 2027-12-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department: revision one day after the primary total hip surgery, due to incomplete seating of the cup.From post-op x-rays it was observed that the cup was not correctly seated.We cannot determine if this is a result of early loss of stability of the cup or if the cup never reached the final seating.The surgeon decided to revise all components.There is no reason to suspect a faulty device.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
• Common Device Name: DOUBLE MOBILITY CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17276833
• Report Number: 3005180920-2023-00478
• Device Sequence Number: 17027879
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 07/07/2023

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 Model Number: 01.32.148MB
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 2218079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2023
• 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: Female