MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 52; DOUBLE MOBILITY ACETABULAR SHELL

Catalog Number 01.26.52MB

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 08/29/2014

Event Type  Injury  

Manufacturer Narrative

On 19 february 2016, the medical affairs director performed a clinical evaluation and commented as follows: aseptic loosening of dual mobility cementless acetabular cup 5 years after implantation.No documentation is supplied, hence clinical analysis is not possible.Mid term aseptic loosening of cementless acetabular cups is a possible complication following thr, reported in literature all over the world.Batch review performed on 29 february 2016.(b)(4).

Event Description

The patient was having aseptic loosening of the acetabular cup.The surgeon removed the cup, head and liner.Medacta's mpact multi hole cup, flat liner and ball head were put in.The surgery was completed successfully.Medacta was notified of the revision on 3 february 2016.The explants and x-rays are not available.

Manufacturer Narrative

On 03 may 2016 it was prepared a final report with the information already submitted in the initial report.On the same date the report was sent to the initial reporter and the case was closed.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 52
• Type of Device: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 5480139
• MDR Text Key: 39670580
• Report Number: 3005180920-2016-00070
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 082271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2008
• 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