MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28

Catalog Number	01.26.2854M
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 13 november 2017.Lot 110327: (b)(4) items manufactured and released on 24 march 2011.Expiration date: 2016-02-29.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.Mectacer biolox forte ceramic ball head 12/14 ø 28 size m 0, code 38.39.7175.255.00, lot.104432 (k073337) (b)(4) items manufactured and released on 18 january 2011.Expiration date: 2015-12-31.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
The patient came in complaining of a leg length discrepancy.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7032801
• Report Number: 3005180920-2017-00660
• Device Sequence Number: 102849
• Product Code: MEH
• UDI-Device Identifier: 07630030807374
• UDI-Public: 07630030807374
• 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: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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: 02/29/2016
• Device Catalogue Number: 01.26.2854M
• Device Lot Number: 110327
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/15/2017
• 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