MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 48

Catalog Number 01.26.45.0048

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

Ct scans were taken and the surgeon suspected that the cup had moved.The surgeon performed the revision via an anterior approach.When he examined the cup intraoperatively, it was mobile.He removed the cup, reamed one size bigger and implanted a 50mm cup with 2 screws.X-rays carried out intraoperatively showed good placement and the surgeon was happy with the fixation.Batch review performed on 27 december 2016.Lot 162918: (b)(4) items manufactured and released on 26 july 2016.Expiration date: 2021-07-07.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.Device not available.

Event Description

The patient presented to the emergency department with a dislocated hip.When the surgeon examined the patient, he established that she had dislocated anteriorly.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 48
• 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: 6215347
• MDR Text Key: 63615793
• Report Number: 3005180920-2016-00694
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 12/30/2016

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: 07/07/2021
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 162918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2016
• 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): Required Intervention
• Patient Age: 74 YR