MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 50/28

Catalog Number	01.26.2850M
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 january 2019: lot 123424: (b)(4) items manufactured and released on 14 november 2012.Expiration date: 2017-10-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director on january 03, 2018, 5.5 years after primary cementless dm tha the surgeon suspects pe wear.We have no report of clinical symptoms.The xray provided does not show major signs of wear or of wear effects, although there are signs of reduced bone density in some areas around the stem, but we have no clinical history and no reports of a painful hip.The ct images of the cup do not allow to infer the presence of macroscopic wear.In our opinion, revision should not be undertaken on the basis of an unsupported assumption of wear unless there is evidence of clinical symptoms.
Event or Problem Description
During a consultation the surgeon detected liner wear.The revision is not scheduled yet.More info will follow the case.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 50/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8217184
• Report Number: 3005180920-2018-01056
• Device Sequence Number: 13867303
• Product Code: MEH
• UDI-Device Identifier: 07630030807275
• UDI-Public: 07630030807275
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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: 10/31/2017
• Device Catalogue Number: 01.26.2850M
• Device Lot Number: 123424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/04/2019
• 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