MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28; ACETABULAR DOUBLE MOBILITY HC LINER

Catalog Number 01.26.2856MHC

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 10/20/2021

Event Type  Injury  

Event Description

Revision surgery was performed due to hip inlay breakage, the patient fell.It is unknown the primary surgery date and all other details.

Manufacturer Narrative

On the 19th of november after the initial report was sent we have received some new information.Batch review performed on 01-dec-2021: lot 160847: (b)(6) items manufactured and released on 21-april-2016.Expiration date: 2021-04-04.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold without any similar reported event.

Event Description

Revision surgery was performed due to hip inlay breakage 4 years and 11 months after the primary surgery, the patient fell and dislocated the hip.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28
• Type of Device: ACETABULAR DOUBLE MOBILITY HC LINER
• 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: 12843240
• MDR Text Key: 281003076
• Report Number: 3005180920-2021-00892
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• 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,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2021
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 160847
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2016
• 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 Sex: Male