MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 4; HIP CEMENTLESS STEM

Model Number	01.39.204
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 january 2020: lot 186934: (b)(4) items manufactured and released on 22-nov-2018.Expiration date: 2023-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain due to a femur fracture.The cause of the femur fracture is unknown.The surgeon cabled the fracture, revised the stem and liner 8 months after primary.The surgery was completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9693712
• Report Number: 3005180920-2020-00054
• Device Sequence Number: 2755851
• Product Code: LZO
• UDI-Device Identifier: 07630030885648
• UDI-Public: 07630030885648
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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: 11/12/2023
• Device Model Number: 01.39.204
• Device Catalogue Number: 01.39.204
• Device Lot Number: 186934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention