MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28

Catalog Number	01.26.2858M
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 june 2018; lot 093130: (b)(4) items manufactured and released on 11 december 2008.Expiration date:2013-10-31; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other device involved: mectacer biolox forte ceramic ball head 12/14 ø 28 size l +3.5 (usa) reference 38.39.7175.265.00 (k073337); lot 083366: (b)(4) items manufactured and released on 19 november 2008.Expiration date: 2013-10-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 9 years after primary the patient was revised for generic hip pain.The surgeon swapped successfully the head and the liner.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7629549
• Report Number: 3005180920-2018-00449
• Device Sequence Number: 13882884
• Product Code: MEH
• UDI-Device Identifier: 07630030807435
• UDI-Public: 07630030807435
• 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: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2018

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: 10/31/2013
• Device Catalogue Number: 01.26.2858M
• Device Lot Number: 083130
• 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: 05/24/2018
• Initial Report FDA Received Date: 06/22/2018
• 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: 70 YR