MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 56/28; DOUBLE MOBILITY HIP LINER

Catalog Number	01.26.2856M
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No information of the loosened stem is available up today.Batch review performed on 27 may 2019: lot 080525: (b)(4) items manufactured and released on 23-apr-2008.Expiration date: 2013-02-28.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed due to stem loosening 8 years and 10 months after primary.Unquantified wear of the double mobility liner was reported (causality not established).Stem, liner and head have been revised.Stem details are not available at the moment.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 56/28
• Common Device Name: DOUBLE MOBILITY HIP LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8645817
• Report Number: 3005180920-2019-00422
• Device Sequence Number: 1941814
• Product Code: MEH
• UDI-Device Identifier: 07630030807404
• UDI-Public: 07630030807404
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083116
• 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): 05/28/2019

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: 02/28/2013
• Device Catalogue Number: 01.26.2856M
• Device Lot Number: 080525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/28/2019
• 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
• Patient Age: 80 YR