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

Catalog Number 01.26.48MB

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2018, lot 122047: 59 items manufactured and released on (b)(6) 2012.Expiration date: (b)(6) 2017.No anomalies found related to the problem.To date, 56 items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in complaining of pain 5 years and half after the primary surgery.The cup had anterior overhang.The surgeon revised the cup, head and liner.The cup and liner were revised with another company's product.The head was revised with another medacta head.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 48
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8064121
• MDR Text Key: 126930462
• Report Number: 3005180920-2018-00891
• Device Sequence Number: 0
• Product Code: MEH
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 122047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2012
• 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