MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 12; HIP CEMENTLESS STEM

Model Number	01.39.412
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	03/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 3 april 2020: lot 180719: (b)(4) items manufactured and released on 11-may-2018.Expiration date: 2023-05-02.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.Clinical evaluation: few weeks after cementless total hip arthroplasty, the patient reported pain due to a femoral fracture.A subclinic intraoperative fracture is probably the cause of this event but also a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.There is no reason to suspect a faulty device.
Event or Problem Description
6 weeks after the primary the patient came in with pain and the x-ray revealed periprosthetic fracture ( probably occurred during the primary surgery).The stem was revised and the fracture was cabled.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 12
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10009048
• Report Number: 3005180920-2020-00260
• Device Sequence Number: 2897707
• Product Code: LZO
• UDI-Device Identifier: 07630040715843
• UDI-Public: 07630040715843
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2020

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: No Information
• Device Expiration Date: 05/02/2023
• Device Model Number: 01.39.412
• Device Catalogue Number: 01.39.412
• Device Lot Number: 180719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/29/2020
• 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
• Patient Age: 68 YR