MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28; DOUBLE MOBILITY ACETABULAR SHELL

Catalog Number	01.26.2848M
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 april 2019: lot 080360: (b)(4) items manufactured and released on 02-jun-2009.Expiration date: 2013-04-30.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any other reported event.
Event or Problem Description
Hip revision surgery 10 years after primary.The reason of revision is unknown at the moment because we received different event description from the agent and from (b)(4).Only cup has been revised.More info will follow this case.
Additional Manufacturer Narrative
The batch release year has been corrected to 02-jun-2008.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28
• Common Device Name: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8564988
• Report Number: 3005180920-2019-00323
• Device Sequence Number: 437870
• Product Code: MEH
• UDI-Device Identifier: 07630030807237
• UDI-Public: 07630030807237
• 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: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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: 04/30/2013
• Device Catalogue Number: 01.26.2848M
• Device Lot Number: 080523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement 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: 44 YR