MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 54; HIP ACETABULAR SHELL

Catalog Number 01.26.54MB

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Disorder (2373)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 october 2019: lot 082537: 8 items manufactured and released on 11-dec-2008.Expiration date: 2013-10-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Additional device involved in the complaint.Batch review performed on 25 october 2019: liner: versafitcup dm 01.26.2854m double mobility liner ø 54/28 (k083116) lot 082980: 24 items manufactured and released on 09-dec-2008.Expiration date: 2013-10-31.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in complaining of pain due to a loose cup that was caused from osteolysis.The surgeon revised the cup, liner, and head almost 10 years and 5 months after primary.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 54
• Type of Device: HIP 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 9334637
• MDR Text Key: 167980610
• Report Number: 3005180920-2019-00969
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• 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: 01.26.54MB
• Device Lot Number: 082537
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• 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