MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 60

Catalog Number	01.26.60MB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 february 2019: lot 091934: (b)(4) items manufactured and released on 25-sep-2009.Expiration date: 2014-08-31.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 by medical affairs manager: partial hip revision surgery (cup, head and liner) occurred 9 years after primary cementless total hip arthroplasty.Radiographic images provided show a mobilized cup.No immediate postoperative x-ray is available, thus initial cup position cannot be assessed.Aspetic loosening is a possible literature described long term adverse event after cementless thr and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
The patient came in due to instability caused by a loose cup 10 years after primary.The surgeon revised the cup, liner and head and the surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 60
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8353653
• Report Number: 3005180920-2019-00070
• Device Sequence Number: 11292698
• Product Code: MEH
• UDI-Device Identifier: 07630030808234
• UDI-Public: 07630030808234
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 076300308082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2019

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: 08/31/2014
• Device Catalogue Number: 01.26.60MB
• Device Lot Number: 091934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2009
• Initial Report FDA Received Date: 02/20/2019
• 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