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

Model Number	01.39.203
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2021-00852
• Device Sequence Number: 3310293
• Product Code: LZO
• UDI-Device Identifier: 07630030885631
• UDI-Public: 07630030885631
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female