MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE Ø 50

Catalog Number 01.26.45.1150

Device Problems Failure To Adhere Or Bond (1031); Unstable (1667)

Patient Problem Joint Dislocation (2374)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

Additional information received on 28 november 2016 and includes: for the moment it looks like the patient didn't dislocate again.Batch reviews performed on 13 december 2016.(b)(4).Not explanted.

Event Description

The patient came in emergency to the hospital due to a hip luxation.The luxation was probably due to a patient bad movement.The patient was anatomically treated but the hip remained unstable.For the moment no revision is planned.If the hip will luxate again, the patient will be revised.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE Ø 50
• 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: 6177046
• MDR Text Key: 62541274
• Report Number: 3005180920-2016-00659
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K122911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2021
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 160228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2016
• 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): Other