MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 54; HIP ACETABULAR SHELL

Catalog Number	01.26.54MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 october 2019: lot 082537: 8 items manufactured and released on 11-dec-2008.Expiration date: 2013-10-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Additional device involved in the complaint.Batch review performed on 25 october 2019: liner: versafitcup dm 01.26.2854m double mobility liner ø 54/28 (k083116) lot 082980: 24 items manufactured and released on 09-dec-2008.Expiration date: 2013-10-31.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in complaining of pain due to a loose cup that was caused from osteolysis.The surgeon revised the cup, liner, and head almost 10 years and 5 months after primary.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 54
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9334637
• Report Number: 3005180920-2019-00969
• Device Sequence Number: 1849981
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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: 10/31/2013
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 082537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/18/2019
• 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