MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 50

Catalog Number	01.26.50MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 march 2018; lot 113555: (b)(4) items manufactured and released on 15 december 2011.Expiration date: 2016-10-31 no anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.
Event or Problem Description
On (b)(6) 2018 the product director hip has been informed by the surgeon that the patient came in complaining of pain.The surgeon believes the cup is loose.The cause of the loosening is unknown.The surgeon plans to revise the cup and liner with another company's product.No additional information is available.On (b)(4) 2018 we were informed that no revision surgery has been scheduled yet.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 50
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7362191
• Report Number: 3005180920-2018-00171
• Device Sequence Number: 13761337
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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: 10/31/2016
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 113555
• 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: 02/22/2018
• Initial Report FDA Received Date: 03/22/2018
• 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: 66 YR