MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø48 TWO-HOLE

Catalog Number	01.32.148DH
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 november 2018.Lot 157817: (b)(4) items manufactured and released on 22 april 2016.Expiration date: 2021-01-13.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.Clinical evaluation performed on october 26, 2018 by medical affairs director: two years after primary cementless tha the patient laments anterior hip pain and the surgeon decides to change the cup position.The pre-revision radiographs confirm that the cup position (limited anteversion, particularly) may be the cause of pain.It is possible that the cup mobilized slightly immediately after primary surgery, because it was found to be solidly ingrown at 2 years.This problem should not be ascribed to a defect intrinsic to the device.Preliminary investigation performed on november 09, 2018 by r&d product manager: the images show the cup just explanted with blood and biological tissue on its surface.From the images it is not possible to determine any root cause related to the event but, from the received information and images we can probably exclude a failure of the device.
Event or Problem Description
About 2 years and 3 months after primary the surgeon revised the patient for a probable early post primary mobilization of the cup successively become very solid with plenty of bony in-growth.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø48 TWO-HOLE
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8054893
• Report Number: 3005180920-2018-00867
• Device Sequence Number: 1683575
• Product Code: LPH
• UDI-Device Identifier: 07630030810732
• UDI-Public: 07630030810732
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

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: 01/13/2021
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 157817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/09/2018
• 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: 50 YR