MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM LINER; ACETABULAR PE LINER

Catalog Number	01.26.2848M
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 22 dec 2017 the medical affairs made the following analysis: partial revision in primary double mobility cementless hip after approx.8 years.The information supplied does not allow a proper analysis to be performed.The radiograph shows a rather protruding cup and a low level of resection of the proximal femur, but there is no establishing a link between these factors and the lamented pain.This peculiar position may have been induced by anatomical constraints, not detectable from the xray provided.The cause for the adverse event cannot be determined.Batch review performed on 02 january 2018: lot 092225: (b)(4) items manufactured and released on 25 september 2009.Expiration date: 2018-08-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery due to pain caused by an inflammation around the joint after 7 years and 9 months from the primary.The surgeon revised head and liner.

• Brand Name: VERSAFITCUP DM LINER
• Common Device Name: ACETABULAR PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7160295
• Report Number: 3005180920-2017-00804
• Device Sequence Number: 1951794
• Product Code: MEH
• UDI-Device Identifier: 07630030807237
• UDI-Public: 07630030807237
• 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: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2018

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: 08/31/2018
• Device Catalogue Number: 01.26.2848M
• Device Lot Number: 092225
• 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: 12/04/2017
• Initial Report FDA Received Date: 01/03/2018
• 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: 52 YR