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

Catalog Number	01.32.148MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 february 2018 lot 155035: (b)(4) items manufactured and released on 12 october 2015.Expiration date: 2018-02-28.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs: partial hip revision surgery (cup, head and liner) occurred 2 years after primary total hip arthroplasty.Radiographic image provided shows the presence of a horizontal cup.The reason of this position cannot be assessed having a single pre-revision low-quality x-ray.The cause of this event cannot be determined on the basis of available information.
Event or Problem Description
The patient came in complaining of iliopsoas pain due to cup mobilization.The surgeon revised the cup, head and liner.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7285365
• Report Number: 3005180920-2018-00072
• Device Sequence Number: 1993924
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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: 02/28/2018
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 155035
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/21/2018
• 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
• Patient Age: 49 YR