MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 52/28; DOUBLE MOBILITY ACETABULAR LINER

Model Number	01.26.2852M
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 july 2021: lot 090085: (b)(4) items manufactured and released on 06-apr-2009.Expiration date: 2014-02-28.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event since 1-jan-2017.Additional implant involved: ball heads: mectacer 38.39.7175.245.00 biolox forte ceramic ball head 12/14 ø 28 size s -3.5 (usa) (k073337) lot.082881.Batch review performed on 01 july 2021: lot 082881: (b)(4) items manufactured and released on 14-oct-2008.Expiration date: 2013-08-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event since 1-1-2017.
Event or Problem Description
11 years and 11 months after primary the patient came in reporting pain and the cause of the pain is unknown.The surgeon revised the head and liner and added a sleeve.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 52/28
• Common Device Name: DOUBLE MOBILITY ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12142141
• Report Number: 3005180920-2021-00577
• Device Sequence Number: 19830679
• Product Code: MEH
• UDI-Device Identifier: 07630030807336
• UDI-Public: 07630030807336
• Combination Product (Y/N): N
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: 02/28/2014
• Device Model Number: 01.26.2852M
• Device Catalogue Number: 01.26.2852M
• Device Lot Number: 090085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/09/2021
• 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