MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM LINER HC 58/28; HIP SHELL LINER

Model Number 01.26.2858MHC

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/26/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2020: lot 171732: (b)(4) items manufactured and released on (b)(6) 2017.Expiration date: 2022-09-03.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.

Event Description

One month after primary surgery, the patient came in reporting pain due to a periprosthetic fracture.The surgeon cabled the fracture, revised the competitor's stem and head, and revised the medacta liner.The surgery was completed successfully.The reason of the fracture is unknown.

• Brand Name: LINER: VERSAFITCUP DM LINER HC 58/28
• Type of Device: HIP SHELL 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: 9980340
• MDR Text Key: 192017090
• Report Number: 3005180920-2020-00253
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807442
• UDI-Public: 07630030807442
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Model Number: 01.26.2858MHC
• Device Catalogue Number: 01.26.2858MHC
• Device Lot Number: 171732
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2017
• 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