MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT SIZE 3; CEMENTLESS FEMORAL STEM

Model Number 01.39.203

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 08-oct-2021: lot 162125: (b)(4) items manufactured and released on 17-jun-2016.Expiration date: 2021-06-06.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medacta medical affairs department: 5 years after primary cementless tha the patient reports pain and the radiograph reveals that the femoral stem is broken at neck level.We have one radiograph, taken after the fracture took place, so we cannot draw any conclusion.The event is extremely rare.Analysis of the explants is mandatory in order to understand the mechanisms of the fracture.

Event Description

Revision surgery performed due to stem neck breakage 4 years and 10 months after the primary surgery (stem and head were replaced).

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT SIZE 3
• Type of Device: CEMENTLESS FEMORAL STEM
• 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: 12758191
• MDR Text Key: 280444573
• Report Number: 3005180920-2021-00852
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030885631
• UDI-Public: 07630030885631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160289
• 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: 11/05/2021

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: 06/06/2021
• Device Model Number: 01.39.203
• Device Catalogue Number: 01.39.203
• Device Lot Number: 162125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2016
• 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: 46 YR
• Patient Sex: Female