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	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed on 16 february 2018: partial hip revision surgery occurred 1 year and 3 months after primary cementless double mobility total hip arthroplasty.Radiographic images provided allow suboptimal evaluation of the cup position and surrounding bone status.Regions of osteolysis are visible in the equatorial region but pictures show the presence of bone adhesion on the cup surface.Aseptic loosening is a possible literature described adverse event after primary cementless tha and reasons are often unknown.In this case, the cause of failure cannot be determined.Batch review performed on 26 february 2018 lot 162385: (b)(4) items manufactured and released on 24 june 2016.Expiration date: 2021-06-15 no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by r&d product manager on 02 march 2018: the mpact shown in the pictures was still explanted.The reasons of the event are unknown as it is not possible to determine the root cause from the received images.
Event or Problem Description
The patient came in complaining of pain 1 year and 3 months after primary.The cup was loose.The cause is unknown.No report of trauma.The surgeon revised the cup, liner and head.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
• Common Device Name: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7309241
• Report Number: 3005180920-2018-00114
• Device Sequence Number: 2300400
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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: 06/24/2016
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 162385
• 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: 01/31/2018
• Initial Report FDA Received Date: 03/02/2018
• 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: 70 YR