MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56

Catalog Number	01.32.156MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 october 2019.Lot 1900195: 51 items manufactured and released on 18-jun-2019.Expiration date: 2024-06-09.No anomalies found related to the problem.To date, 29 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director.Dislocation due to implant mobilization occurred in day 1 after cementless total hip arthroplasty.The cup was incompletely seated in the bone due to insufficient acetabular preparation.The reason of this choice is unknown: one reason may be patient particular anatomy or bone morphology that cannot be assessed as no preoperative image is available.There is no reason to suspect a faulty device.
Event or Problem Description
The patient came in complaining of pain, and the cause of the pain was a dislocation.Post-op x-rays indicated that the cup was placed too lateral which caused a dislocation.The surgeon revised the cup 1 day after primary surgery.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56
• Common Device Name: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9260078
• Report Number: 3005180920-2019-00912
• Device Sequence Number: 2055170
• Product Code: LPH
• UDI-Device Identifier: 07630030860997
• UDI-Public: 07630030860997
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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: 06/09/2024
• Device Catalogue Number: 01.32.156MB
• Device Lot Number: 1900195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/31/2019
• 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