MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL CC TRIO DIAM. 54

Catalog Number 01.26.45.0054

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 03/26/2016

Event Type  Injury  

Manufacturer Narrative

Additional information received on 06 april 2016 and includes: the surgery was completed successfully.

Event Description

The patient complained of pain.The surgeon found that the cup was protruding into the pelvis.The surgeon believes this was due to poor bone quality.A revision surgery was planned.X-rays and explants are not available.

Manufacturer Narrative

Batch review performed on 19 may 2016.Lot 135968: (b)(4) items manufactured and released on 03 february 2014.Expiration date: 2018-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.On 19 may 2016 it was prepared a final report with the information submitted in this report and in the previous one.On 23 max 2016 the report was sent to the initial reporter and the case was closed.

• Brand Name: VERSAFITCUP ACETABULAR SHELL CC TRIO DIAM. 54
• Type of Device: 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: 5603810
• MDR Text Key: 43505437
• Report Number: 3005180920-2016-00183
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103352
• 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: 05/23/2016

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: 12/31/2018
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 135968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2016
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2014
• 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
• Patient Age: 58 YR