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

Catalog Number	01.26.2848M
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 24 nov 2017 the medical affairs director made the following analysis: partial revision (head and cup) of a primary double mobility cementless tha after 8 years.Pain was reported.One image only is supplied, an intra-operative fluoroscopy, date unknown.The only detail apparent from it is a rather proud cup in the cranial aspect, that may have psoas impingement, although the implant did work for 8 years.No comparison between images is possible, therefore cup mobilization cannot be determined.We could not recognize any indication of a defective implant.On 30 nov 2017 the r and d project manager checked the retrieved images of the explants commenting as following: no particular sign can be noted on the implants.The root cause of the event cannot be determined.Batch review performed on 30 november 2017: (b)(4).
Event or Problem Description
The patient came in complaining of pain.The cause of pain is unknown.The surgeon revised the head, cup and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2017, lot 090897: (b)(4) items manufactured and released on (b)(4) 2009.Expiration date: (b)(6) 2014.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 pain.The surgeon revised the head, cup and liner.Additional information received on 30 nov 2017 by the complainer: there was small evidence of osteolysis which most likely was the cause of pain.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY LINER Ø 48/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7070540
• Report Number: 3005180920-2017-00713
• Device Sequence Number: 16433927
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2017

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: 04/30/2014
• Device Catalogue Number: 01.26.2848M
• Device Lot Number: 090897
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/29/2017
• 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