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

Catalog Number	01.26.2858MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 28 august 2017.Lot 133478: (b)(4) items manufactured and released on 30 august 2013.Expiration date: 2018-07-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on this lot.Cocr ball head 12/14 ø 28 size s -3.5, code 01.25.011, lot.130909 (k072857) lot 130909: (b)(4) items manufactured and released on 15 april 2013.Expiration date: 2018-03-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold and this is the third similar event reported on this lot.
Event or Problem Description
The patient came in due to signs of infection.The pathogen is confirmed as staphyloccocus.The surgeon swapped the head and liner.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 58/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6829710
• Report Number: 3005180920-2017-00480
• Device Sequence Number: 16524646
• Product Code: MEH
• UDI-Device Identifier: 07630030807442
• UDI-Public: 07630030807442
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: 07/31/2018
• Device Catalogue Number: 01.26.2858MHC
• Device Lot Number: 133478
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/30/2017
• 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