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

Catalog Number 01.26.2850M

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 12/05/2018

Event Type  Injury  

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 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
• Type of Device: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8217184
• MDR Text Key: 132070549
• Report Number: 3005180920-2018-01056
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807275
• UDI-Public: 07630030807275
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 01.26.2850M
• Device Lot Number: 123424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention